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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wax, bone
510(k) Number K113079
Device Name SYNTHES HEMOSTATIC BONE PUTTY
Applicant
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
1230 Wilson Dr
West Chester,  PA  19380
Applicant Contact JEFFREY L DOW
Correspondent
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
1230 Wilson Dr
West Chester,  PA  19380
Correspondent Contact JEFFREY L DOW
Classification Product Code
MTJ  
Date Received10/17/2011
Decision Date 12/13/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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