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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 K964366
Device Name EAGLE EYES
Applicant
Mech-Tronic Precision Mfg., Ltd.
Flat 4, 9/F., Fu Nga House
Fu Keung Court
Kowloon,  HK
Applicant Contact FUNG SIU KWAN
Correspondent
Mech-Tronic Precision Mfg., Ltd.
Flat 4, 9/F., Fu Nga House
Fu Keung Court
Kowloon,  HK
Correspondent Contact FUNG SIU KWAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/01/1996
Decision Date 01/29/1997
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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