The Code of Federal Regulations of the United States of AmericaThe Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.5. rezultāts no 5.
331. lappuse
( 2 ) Classification . Class II ( special controls ) . The special control for this device
is FDA ' s guidance document entitled Class II Special Controls Guidance
Document : Dental Sonography and Jaw Tracking Devices . " [ 68 FR 67367 ,
Dec .
( 2 ) Classification . Class II ( special controls ) . The special control for this device
is FDA ' s guidance document entitled Class II Special Controls Guidance
Document : Dental Sonography and Jaw Tracking Devices . " [ 68 FR 67367 ,
Dec .
339. lappuse
The guidance document entitled " Class II Special Controls Guidance Document :
Root - Form Endosseous Dental Implants and Endosseous Dental Implant
Abutments " will serve as the special control . ( See 8872 . 1 ( e ) for the
availability of ...
The guidance document entitled " Class II Special Controls Guidance Document :
Root - Form Endosseous Dental Implants and Endosseous Dental Implant
Abutments " will serve as the special control . ( See 8872 . 1 ( e ) for the
availability of ...
347. lappuse
The special control is FDA ' s ... Class I if the teething ring does not contain a fluid
, such as water . ... The special control for these devices is the FDA guidance
document entitled Class II Special Controls Guidance Document : Intraoral ...
The special control is FDA ' s ... Class I if the teething ring does not contain a fluid
, such as water . ... The special control for these devices is the FDA guidance
document entitled Class II Special Controls Guidance Document : Intraoral ...
396. lappuse
Class II ( special Also , the suture may be provided with controls ) . The special
control for this or without a standard needle attached . device is FDA ' s Class II
Special Con( b ) Classification . Class II ( special trols Guidance Document ...
Class II ( special Also , the suture may be provided with controls ) . The special
control for this or without a standard needle attached . device is FDA ' s Class II
Special Con( b ) Classification . Class II ( special trols Guidance Document ...
434. lappuse
Class II ( special trical current to electrodes on a patient ' s skin to treat pain .
controls . ) The special control for this ( b ) Classification . Class II ( performdevice
is the FDA guidance document entitled Class II Special Controls ance standards
) ...
Class II ( special trical current to electrodes on a patient ' s skin to treat pain .
controls . ) The special control for this ( b ) Classification . Class II ( performdevice
is the FDA guidance document entitled Class II Special Controls ance standards
) ...
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accessories accordance amended amended at 65 ance standards application approval blood body caused chapter subject Class II perform Class II special Classification clinical commercial distribution completion component consists container designed determine device intended device is exempt diagnosis disease document effective electrical equipment established evaluation facility Federal files fluid Food and Drug Guidance hearing human Identification implanted indicate joint July 25 June labeling limitations manufacturer material means measure ment monitor notice operation paragraph patient person placed powered practice premarket notification procedures pressure procedures in subpart prosthesis reagents reasonable records regulation request respect Sept serum special controls specific statement submit subpart E surgical test system tion tissue treatment trols tube unit unless vice x-ray
Populāri fragmenti
11. lappuse - Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label space for the...
18. lappuse - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.
356. lappuse - Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.
86. lappuse - In computing any period of time prescribed or allowed by this part, the day of the act, event, or default after which the designated period of time begins to run is not to be included. The last day of the period so computed is to be included, unless it is...
79. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any substance; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears...
578. lappuse - Nothing in this section shall authorize the withholding of information by the Secretary or any officer or employee under his control, from the duly authorized committees of the Congress.
15. lappuse - On packages containing 4 pounds or 1 gallon or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fractions of the pound; in the case of fluid measure, it shall be expressed in the largest whole unit...
15. lappuse - 6 oz net wt.," and "6 fl oz" or "net contents 6 fl oz". (j) On packages containing 4 pounds or 1 gallon or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fractions of the pound...
56. lappuse - (1) the term 'manufacture, preparation, propagation, compounding, or processing' shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; "(2) the term 'name...