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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 K972490
Device Name D'ARC EYE CARE SUNGLASSES
Applicant
M & R Dist.
1219 Sunset Plz. Dr., #4
Los Angeles,  CA  90069
Applicant Contact MAX SHER
Correspondent
M & R Dist.
1219 Sunset Plz. Dr., #4
Los Angeles,  CA  90069
Correspondent Contact MAX SHER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/02/1997
Decision Date 07/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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