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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 K935037
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
XIAMEN CHENYI PLASTICS INDUSTRIAL CO. LTD.
PU NAN, WU CUN
XIAMEN, MAINLAND,  CN 361004
Applicant Contact TANG-YU WU
Correspondent
XIAMEN CHENYI PLASTICS INDUSTRIAL CO. LTD.
PU NAN, WU CUN
XIAMEN, MAINLAND,  CN 361004
Correspondent Contact TANG-YU WU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/18/1993
Decision Date 04/29/1994
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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