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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 K970538
Device Name VICTORY EYEWEAR CO
Applicant
Victory Eyewear Co., Ltd.
#8 Lane 279 Chung Cheng Rd.
Yung Kang City, Taiwan Hsien,  TW
Applicant Contact MICHAEL CHEN
Correspondent
Victory Eyewear Co., Ltd.
#8 Lane 279 Chung Cheng Rd.
Yung Kang City, Taiwan Hsien,  TW
Correspondent Contact MICHAEL CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/12/1997
Decision Date 03/25/1997
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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