HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY

Wax, Bone

ORTHOCON, INC.

The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hbp4 Hardening, Resorbable Hemostatic Bone Putty.

Pre-market Notification Details

Device IDK141502
510k NumberK141502
Device Name:HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
ClassificationWax, Bone
Applicant ORTHOCON, INC. 1 Bridge St Ste 121 Irvington,  NY  10533
ContactHoward Schrayer
CorrespondentHoward Schrayer
ORTHOCON, INC. 1 Bridge St Ste 121 Irvington,  NY  10533
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-06
Decision Date2014-10-03
Summary:summary

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