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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 K941138
Device Name SG-22 SUNGLASSES
Applicant
American Bestin Mfg., Inc.
2437 N. Lee Ave.
South El Monte,  CA  91733
Applicant Contact ROY HUANG
Correspondent
American Bestin Mfg., Inc.
2437 N. Lee Ave.
South El Monte,  CA  91733
Correspondent Contact ROY HUANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/10/1994
Decision Date 04/29/1994
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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