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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameAQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberP880101
Supplement NumberS005
Date Received07/03/1991
Decision Date12/03/1991
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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