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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K943507
Device Name WINK EYEWEAR
Applicant
Wink Optical, Inc.
101 W. 31st St.
New York,  NY  10001
Applicant Contact JULIE KOCH-BEINKE
Correspondent
Wink Optical, Inc.
101 W. 31st St.
New York,  NY  10001
Correspondent Contact JULIE KOCH-BEINKE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/20/1994
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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