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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 K955287
Device Name ZONG RONG SUNGLASSES
Applicant
Yuu Yeng Enterprise Co., Ltd.
1st Floor # 174,
Chung Hsueh Rd.
Tainan,  TW 510850
Applicant Contact CHI-TSUNG SHIH
Correspondent
Yuu Yeng Enterprise Co., Ltd.
1st Floor # 174,
Chung Hsueh Rd.
Tainan,  TW 510850
Correspondent Contact CHI-TSUNG SHIH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/17/1995
Decision Date 01/29/1996
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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