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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameQUASEPT II
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION OPHTHALMIC PRODUCTS
PMA NumberN17679
Supplement NumberS016
Date Received11/09/1987
Decision Date12/01/1987
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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