HEMASORBPLUS Press Resorable Hemostatic Bone Putty

Wax, Bone

ORTHOCON, INC.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hemasorbplus Press Resorable Hemostatic Bone Putty.

Pre-market Notification Details

Device IDK143069
510k NumberK143069
Device Name:HEMASORBPLUS Press Resorable Hemostatic Bone Putty
ClassificationWax, Bone
Applicant ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington,  NY  10533
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
ORTHOCON, INC. 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 Received2014-10-27
Decision Date2014-12-22
Summary:summary

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