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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K944313
Device Name SPECTACLE FRAME
Applicant
Sun Hing Optical Manufactory , Ltd.
Unit 1001c 10/F Sunbeam Center
27 Shing Yip St.
Kwun Tong, Kowloon, Hong Kong,  HK
Applicant Contact PHYLLIS KU
Correspondent
Sun Hing Optical Manufactory , Ltd.
Unit 1001c 10/F Sunbeam Center
27 Shing Yip St.
Kwun Tong, Kowloon, Hong Kong,  HK
Correspondent Contact PHYLLIS KU
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/29/1994
Decision Date 03/28/1995
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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