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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 K922464
Device Name SUNGLASSES
Applicant
Wing Shing Optical Manufacturers , Ltd.
4/F., Rm. 1, Sino Industrial
Plz., 9 Kai Cheung Rd.
Kowloon Bay, Kowloon,  HK
Correspondent
Wing Shing Optical Manufacturers , Ltd.
4/F., Rm. 1, Sino Industrial
Plz., 9 Kai Cheung Rd.
Kowloon Bay, Kowloon,  HK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/26/1992
Decision Date 01/27/1993
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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