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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 K946004
Device Name FI, GORDY TOY, WELLJOY AND OTHERS
Applicant
Fundamental Industrial Co., Ltd.
1/F Yip Hing Factory Bldg
332 Hwun Tong Rd.
Kowloon, Hong Kong,  HK
Applicant Contact CHOW M TAI
Correspondent
Fundamental Industrial Co., Ltd.
1/F Yip Hing Factory Bldg
332 Hwun Tong Rd.
Kowloon, Hong Kong,  HK
Correspondent Contact CHOW M TAI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/09/1994
Decision Date 01/31/1995
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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