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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
T.A.G. MEDICAL PRODUCTS
291 Hillside Avenue
Somerset,  MA  02726
Applicant Contact GEORGIE J HATTUB
Correspondent
T.A.G. MEDICAL PRODUCTS
291 Hillside Avenue
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
Recalls CDRH Recalls
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