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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 K926096
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Lunettes Bondet
Boite Postale 116-01104oyonnax
Cedex, Siege Social 20 Rue J.
J.Rousseau Oyonnax,France,  FR
Applicant Contact BONDET
Correspondent
Lunettes Bondet
Boite Postale 116-01104oyonnax
Cedex, Siege Social 20 Rue J.
J.Rousseau Oyonnax,France,  FR
Correspondent Contact BONDET
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/02/1992
Decision Date 09/20/1993
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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