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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 K952758
Device Name GOUVERNEUR AUDIGIER
Applicant
ETS GOUVERNEUR-AUDIGIER
66, RUE DE LA REPUBLIQUE
MOREZ,  FR 39400
Applicant Contact GUSTAV M HEIMBUCHER
Correspondent
ETS GOUVERNEUR-AUDIGIER
66, RUE DE LA REPUBLIQUE
MOREZ,  FR 39400
Correspondent Contact GUSTAV M HEIMBUCHER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/16/1995
Decision Date 08/07/1995
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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