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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 K943567
Device Name FACONNABLE EYEWEAR
Applicant
Blink Designs, Inc.
6307 Desoto Ave., Suite A
Woodland Hills,  CA  91367
Applicant Contact BRIAN JABLON
Correspondent
Blink Designs, Inc.
6307 Desoto Ave., Suite A
Woodland Hills,  CA  91367
Correspondent Contact BRIAN JABLON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/22/1994
Decision Date 08/10/1994
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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