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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 K943265
Device Name N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO
Applicant
The First Optical Manufactory , Ltd.
36 Mok Cheong St., Flat B-1,
11th Floor , Luen Ming Hing Bldg.
Tokwawan, Kowloon,  HK
Applicant Contact REGULATORY AFFAIRS PERSON
Correspondent
The First Optical Manufactory , Ltd.
36 Mok Cheong St., Flat B-1,
11th Floor , Luen Ming Hing Bldg.
Tokwawan, Kowloon,  HK
Correspondent Contact REGULATORY AFFAIRS PERSON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/07/1994
Decision Date 08/05/1994
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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