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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 K962382
Device Name XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
Applicant
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
23 SHIN YUNG ROAD
XIAMEN, FUCHIEN,  CN
Applicant Contact SUN-MOU LEE
Correspondent
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
23 SHIN YUNG ROAD
XIAMEN, FUCHIEN,  CN
Correspondent Contact SUN-MOU LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/20/1996
Decision Date 07/25/1996
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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