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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 K113627
Device Name HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
Applicant
ORTHOCON
1 BRIDGE STREET
SUITE 121
IRVINGTON,  NY  10533
Applicant Contact ROSEMARY HARRY
Correspondent
ORTHOCON
1 BRIDGE STREET
SUITE 121
IRVINGTON,  NY  10533
Correspondent Contact ROSEMARY HARRY
Classification Product Code
MTJ  
Date Received12/08/2011
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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