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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 K940778
Device Name SUNGLASSES (NON-PRESCRIPTION)
Applicant
Hwa Meei Optical Co., Ltd.
28-2, Sha-Luen
Chung Sha Village
Tainan, China (Taiwan) 745,  TW 745
Applicant Contact CHENG HAU CHEN
Correspondent
Hwa Meei Optical Co., Ltd.
28-2, Sha-Luen
Chung Sha Village
Tainan, China (Taiwan) 745,  TW 745
Correspondent Contact CHENG HAU CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/22/1994
Decision Date 04/06/1994
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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