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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 K941338
Device Name CHANG CHENG CHUNG
Applicant
Designer Brass Corp.
27 21st Rd.,
Taichung Industrial Park
Taichung,  TW
Applicant Contact EMMY M.I. SOONG
Correspondent
Designer Brass Corp.
27 21st Rd.,
Taichung Industrial Park
Taichung,  TW
Correspondent Contact EMMY M.I. SOONG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/21/1994
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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