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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K083096
Device Name LATARJET CORTICAL SCREW SET
Applicant
Tag Medical Products
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Tag Medical Products
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/17/2008
Decision Date 04/17/2009
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
Recalls CDRH Recalls
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