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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 NameAIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
Classification Namelens, contact (polymethylmethacrylate)
ApplicantWESLEY JESSEN CORP.
PMA NumberP830070
Supplement NumberS004
Date Received08/01/1986
Decision Date04/13/1988
Product Code
HPX[ Registered Establishments with HPX ]
Docket Number 88M-0185
Notice Date 06/27/1988
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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