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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 K944568
Device Name SUNGLASSES
Applicant
Great Field Industries Co., Ltd.
1 Floor , #109, Min Chuan Rd.
Hsin Tien City, Taipei Hsien,  TW
Applicant Contact JERRY CHAO
Correspondent
Great Field Industries Co., Ltd.
1 Floor , #109, Min Chuan Rd.
Hsin Tien City, Taipei Hsien,  TW
Correspondent Contact JERRY CHAO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/19/1994
Decision Date 01/09/1995
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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