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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 K943263
Device Name NIL
Applicant
Sing Wah International Enterprises , Ltd.
4010-4018 Jardine House,
1 Connaught Pl. Centre
Connaught,  HK
Applicant Contact REGULATORY AFFAIRS PERSON
Correspondent
Sing Wah International Enterprises , Ltd.
4010-4018 Jardine House,
1 Connaught Pl. Centre
Connaught,  HK
Correspondent Contact REGULATORY AFFAIRS PERSON
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received07/07/1994
Decision Date 08/15/1994
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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