OPTIUM DBM GEL AND PUTTY

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

LIFENET

The following data is part of a premarket notification filed by Lifenet with the FDA for Optium Dbm Gel And Putty.

Pre-market Notification Details

Device IDK053098
510k NumberK053098
Device Name:OPTIUM DBM GEL AND PUTTY
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant LIFENET 5809 WARD CT. Virginia Beach,  VA  23455
ContactDavid Klementowski
CorrespondentDavid Klementowski
LIFENET 5809 WARD CT. Virginia Beach,  VA  23455
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-03
Decision Date2005-11-28
Summary:summary

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