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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 K933905
Device Name ASICS SUNGLASSES
Applicant
Asics Tiger Corp.
10540 Talbert Ave.
Fountain Valley,  CA  92708
Applicant Contact NANCY BURNS
Correspondent
Asics Tiger Corp.
10540 Talbert Ave.
Fountain Valley,  CA  92708
Correspondent Contact NANCY BURNS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/11/1993
Decision Date 10/18/1993
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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