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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 K914310
Device Name OPTICAL FRAMES & SUNGLASSES
Applicant
Societe Nouvelle Idc
27, Rue Du Four-A-Chaux -
B.P. 29 - 13262 Marseille,
Cedex 07, Paris, France,  FR
Applicant Contact REGINE CLEMENT
Correspondent
Societe Nouvelle Idc
27, Rue Du Four-A-Chaux -
B.P. 29 - 13262 Marseille,
Cedex 07, Paris, France,  FR
Correspondent Contact REGINE CLEMENT
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/25/1991
Decision Date 02/19/1992
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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