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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 K101616
Device Name THE GRAPPLR AND GRAPPLR EXTENDER
Applicant
Tag Medical Corp.
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Tag Medical Corp.
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received06/09/2010
Decision Date 01/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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