OsteoSeal Bone Hemostat

Wax, Bone

HEMOSTASIS, LLC

The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Osteoseal Bone Hemostat.

Pre-market Notification Details

Device IDK142348
510k NumberK142348
Device Name:OsteoSeal Bone Hemostat
ClassificationWax, Bone
Applicant HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul,  MN  55110
ContactBernard Horwath
CorrespondentBernard Horwath
HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul,  MN  55110
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-22
Decision Date2015-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858439001569 K142348 000
00858439001545 K142348 000
00858439001514 K142348 000

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