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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 K950193
Device Name PHILIPPE CHARRIOL
Applicant
Philippe Charriol Dist., Inc.
2335 NW 107th Ave.
Suite C9, Box 64
Miami,  FL  33172
Applicant Contact DOMINIQUE GERENTE
Correspondent
Philippe Charriol Dist., Inc.
2335 NW 107th Ave.
Suite C9, Box 64
Miami,  FL  33172
Correspondent Contact DOMINIQUE GERENTE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/18/1995
Decision Date 02/24/1995
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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