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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, NORTH DURFEE AVE.
el monte,  CA  91732
Applicant Contact shally yuan
Correspondent
20/20 ENT.
2705-B, NORTH 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
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