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.
319. lappuse
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 9 , 1987 for any replacement
heart valve that was in commercial distribution before May 28 , 1976 , or that has
on or ...
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 9 , 1987 for any replacement
heart valve that was in commercial distribution before May 28 , 1976 , or that has
on or ...
343. lappuse
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before March 30 , 1999 , for any total
temporomandibular joint prosthesis that was in commercial distribution before
May 28 , 1976 , or ...
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before March 30 , 1999 , for any total
temporomandibular joint prosthesis that was in commercial distribution before
May 28 , 1976 , or ...
370. lappuse
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administra - tion on or before July 11 , 2000 , for any penile inflatable
implant that was in commercial distribution before May 28 , 1976 , or that has , on
or ...
A PMA or a notice of completion of a PDP is required to be filed with the Food
and Drug Administra - tion on or before July 11 , 2000 , for any penile inflatable
implant that was in commercial distribution before May 28 , 1976 , or that has , on
or ...
432. lappuse
stimulator that was in commercial distribution before May 28 , 1976 , or that has
on or before July 7 , 1986 been found to be substantially equivalent to an
implanted diaphragmatic / phrenic nerve stimulator that was in commercial
distribution ...
stimulator that was in commercial distribution before May 28 , 1976 , or that has
on or before July 7 , 1986 been found to be substantially equivalent to an
implanted diaphragmatic / phrenic nerve stimulator that was in commercial
distribution ...
489. lappuse
uncemented prosthesis that was in metacarpophalangeal ( finger ) joint .
commercial distribution before May 28 , This device prevents dislocation in 1976 .
Any other elbow joint humeral more than one anatomic plane and has ( hemi -
elbow ) ...
uncemented prosthesis that was in metacarpophalangeal ( finger ) joint .
commercial distribution before May 28 , This device prevents dislocation in 1976 .
Any other elbow joint humeral more than one anatomic plane and has ( hemi -
elbow ) ...
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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...