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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 K952734
Device Name HENNERT SA
Applicant
Hennert S.A.
42 Ave. Du Marechal Leclerc
Bois Le Roi,  FR 77590
Applicant Contact VERONIQUE DAMAR
Correspondent
Hennert S.A.
42 Ave. Du Marechal Leclerc
Bois Le Roi,  FR 77590
Correspondent Contact VERONIQUE DAMAR
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/15/1995
Decision Date 08/08/1995
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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