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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 K943963
Device Name NIL
Applicant
Max-Vision (H.K.)Limited
33-34 Au Pui Wan St.
Rm.5
Fotan, New Territories,  HK
Applicant Contact TEE LEE
Correspondent
Max-Vision (H.K.)Limited
33-34 Au Pui Wan St.
Rm.5
Fotan, New Territories,  HK
Correspondent Contact TEE LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/15/1994
Decision Date 09/14/1994
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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