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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 K091694
Device Name MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
Applicant
Tag Medical Products
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGIE J HATTUB
Correspondent
Tag Medical Products
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGIE J HATTUB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/10/2009
Decision Date 07/07/2009
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
Recalls CDRH Recalls
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