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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 K941463
Device Name SPECTACLE FRAMES, READING GLASSES
Applicant
Well Arts Optical Factory , Ltd.
5-7 Wong Chuk Yeung St.
Fo Tan, Shatin, N.T.
Hong Kong,  HK
Applicant Contact KING-YU MA
Correspondent
Well Arts Optical Factory , Ltd.
5-7 Wong Chuk Yeung St.
Fo Tan, Shatin, N.T.
Hong Kong,  HK
Correspondent Contact KING-YU MA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/28/1994
Decision Date 06/17/1994
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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