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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 K941629
Device Name SUNGLASSES
Applicant
Kuang Yauh Optical Co., Ltd.
#6, Ln. 157, Sec 1 Hai Diann
Rd. An Nan
Tainan 70203,  TW
Applicant Contact GEORGE YU
Correspondent
Kuang Yauh Optical Co., Ltd.
#6, Ln. 157, Sec 1 Hai Diann
Rd. An Nan
Tainan 70203,  TW
Correspondent Contact GEORGE YU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/04/1994
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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