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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K941084
Device Name SUNGLASSES
Applicant
Blue Gem Sunglasses, Inc.
6381 Unit B
Rose Ln.
Carpinteria,  CA  93013
Applicant Contact DAVID WEINSTEIN
Correspondent
Blue Gem Sunglasses, Inc.
6381 Unit B
Rose Ln.
Carpinteria,  CA  93013
Correspondent Contact DAVID WEINSTEIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/08/1994
Decision Date 08/14/1995
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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