HEMASORB Resorbable Hemostatic Bone Putty

Wax, Bone

ORTHOCON, LLC

The following data is part of a premarket notification filed by Orthocon, Llc with the FDA for Hemasorb Resorbable Hemostatic Bone Putty.

Pre-market Notification Details

Device IDK142339
510k NumberK142339
Device Name:HEMASORB Resorbable Hemostatic Bone Putty
ClassificationWax, Bone
Applicant ORTHOCON, LLC 1 Bridge Street -Suite 121 Irvington,  NY  10533
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
ORTHOCON, LLC 1 Bridge Street -Suite 121 Irvington,  NY  10533
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-21
Decision Date2014-09-26
Summary:summary

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