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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 K941053
Device Name NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES
Applicant
Hsin Chen Intl. Co., Ltd.
P.O. Box 55-792 7th Floor 206 Sung
Chiang Rd.
Taipei, Taiwan,  TW
Applicant Contact JACK HO
Correspondent
Hsin Chen Intl. Co., Ltd.
P.O. Box 55-792 7th Floor 206 Sung
Chiang Rd.
Taipei, Taiwan,  TW
Correspondent Contact JACK HO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/03/1994
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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