NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE

Filler, Bone Void, Calcium Compound

NovaBone Products, LLC

The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone - Ar - Resorbable Bone Graft Substitute.

Pre-market Notification Details

Device IDK041613
510k NumberK041613
Device Name:NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
ClassificationFiller, Bone Void, Calcium Compound
Applicant NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua,  FL  32615
ContactDavid M Gaisser
CorrespondentDavid M Gaisser
NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua,  FL  32615
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-15
Decision Date2004-08-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.