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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 K954075
Device Name YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
Applicant
Yo Nan Sunglasses Co., Ltd.
# 5 Tai Yi 5th St.
1 Chia Village Jen Te Shiang
Tainan Hsien,  TW R.O.C.
Applicant Contact H. Y. LIEN
Correspondent
Yo Nan Sunglasses Co., Ltd.
# 5 Tai Yi 5th St.
1 Chia Village Jen Te Shiang
Tainan Hsien,  TW R.O.C.
Correspondent Contact H. Y. LIEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/30/1995
Decision Date 09/12/1995
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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