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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 K946381
Device Name SUNGLASSES
Applicant
Ialin Optical Mfg., (H.K.) Co. , Ltd.
2/F., Middle Blk, Man Wai Bldg
9 Man Cheong St. Ferry Pt.
Yaumati, Kln.,  HK
Applicant Contact WONG CHI KAU
Correspondent
Ialin Optical Mfg., (H.K.) Co. , Ltd.
2/F., Middle Blk, Man Wai Bldg
9 Man Cheong St. Ferry Pt.
Yaumati, Kln.,  HK
Correspondent Contact WONG CHI KAU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/27/1994
Decision Date 02/22/1995
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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