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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 K951801
Device Name MING-YA OPTICAL INDUSTRIALCO., LTD.
Applicant
Min-Ya Optical Industrial Co., Ltd.
104-1, Lu Su Ten,
Ming Hsung,
Chiayi,  TW 62101
Applicant Contact HONG-YU SHIH
Correspondent
Min-Ya Optical Industrial Co., Ltd.
104-1, Lu Su Ten,
Ming Hsung,
Chiayi,  TW 62101
Correspondent Contact HONG-YU SHIH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/18/1995
Decision Date 08/14/1995
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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