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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 K941432
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Large River Industrial Co., Ltd.
# 13, Ln. 243, Sec. 1
Hai Tien Rd.
Tainan,  TW
Applicant Contact CHIN H CHENG
Correspondent
Large River Industrial Co., Ltd.
# 13, Ln. 243, Sec. 1
Hai Tien Rd.
Tainan,  TW
Correspondent Contact CHIN H CHENG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/24/1994
Decision Date 06/06/1994
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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