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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 K940730
Device Name YON'S JAY ENTERPRISE CO
Applicant
Yon'S Jay Enterprise Co.
P.O. Box 10-34
Tainan, Taiwan,  TW
Applicant Contact TINA TSAI
Correspondent
Yon'S Jay Enterprise Co.
P.O. Box 10-34
Tainan, Taiwan,  TW
Correspondent Contact TINA TSAI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/18/1994
Decision Date 04/12/1994
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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