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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 K940488
Device Name CHEN-HERSIN SUNGLASSES
Applicant
Chen Hersin Ent.
P.O. Box 10-43
Tainan,Taiwan, China,  TW
Applicant Contact STEVE L CHEN
Correspondent
Chen Hersin Ent.
P.O. Box 10-43
Tainan,Taiwan, China,  TW
Correspondent Contact STEVE L CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/04/1994
Decision Date 07/12/1994
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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