GRAFTON PLUS DBM PASTE

Bone Grafting Material, Human Source

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Grafton Plus Dbm Paste.

Pre-market Notification Details

Device IDK042707
510k NumberK042707
Device Name:GRAFTON PLUS DBM PASTE
ClassificationBone Grafting Material, Human Source
Applicant OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
ContactChristopher Talbot
CorrespondentChristopher Talbot
OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-30
Decision Date2005-11-30
Summary:summary

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