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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 K123243
Device Name HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
Applicant
Orthocon, Inc.
1 Bridge St., Suite 121
Irvington,  NY  10533
Applicant Contact Howard Schrayer
Correspondent
Orthocon, Inc.
1 Bridge St., Suite 121
Irvington,  NY  10533
Correspondent Contact Howard Schrayer
Classification Product Code
MTJ  
Date Received10/17/2012
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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