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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 K941076
Device Name SUNGLASSES AND SPORT SUNGLASSES
Applicant
20/20 Ent.
2705-B, N. Durfee Ave.
El Monte,  CA  91732
Applicant Contact SHALLY YUAN
Correspondent
20/20 Ent.
2705-B, N. Durfee Ave.
El Monte,  CA  91732
Correspondent Contact SHALLY YUAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/08/1994
Decision Date 04/12/1994
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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