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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact (other material) - daily
510(k) Number K962934
Device Name AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR
Applicant
AIRPERM, INC.
4505 VAN NUYS BLVD.
SHERMAN OAKS,  CA  91403
Applicant Contact NICK STOYAN
Correspondent
AIRPERM, INC.
4505 VAN NUYS BLVD.
SHERMAN OAKS,  CA  91403
Correspondent Contact NICK STOYAN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received07/29/1996
Decision Date 08/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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