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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 K941280
Device Name SUNGLASSES (NON PRESCRIPTION)
Applicant
Autotime Industry, Inc.
2fl.#157,Sec 2, Hsin-Hai Rd.
Taipei, Taiwan,  TW 10673
Applicant Contact CHARLES CHOU
Correspondent
Autotime Industry, Inc.
2fl.#157,Sec 2, Hsin-Hai Rd.
Taipei, Taiwan,  TW 10673
Correspondent Contact CHARLES CHOU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/17/1994
Decision Date 05/17/1994
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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