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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K142653
Device Name G-Lok and G-Lok XL Extender
Applicant
T.A.G. Medical Products Corporation, Ltd.
D. N. Ashrat
Kibbutz Gatton,  IL 25130
Applicant Contact Tomer Alon
Correspondent
Medicsense USA
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George J Hattub
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/18/2014
Decision Date 10/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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