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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 K193052
Device Name HBP6 Settable, Resorbable Hemostatic Bone Paste
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 Received11/01/2019
Decision Date 03/27/2020
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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