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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 K915266
Device Name VISOR SUNGLASSES/LENS/NOVELTY VISOR
Applicant
Janlin Ent.
4001 Pacific Coast Hwy.
Suite 408
Torrance,  CA  90505
Applicant Contact JANET L TIGHE
Correspondent
Janlin Ent.
4001 Pacific Coast Hwy.
Suite 408
Torrance,  CA  90505
Correspondent Contact JANET L TIGHE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/20/1991
Decision Date 09/02/1992
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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