GRAFTON DBM

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 Dbm.

Pre-market Notification Details

Device IDK051188
510k NumberK051188
Device Name:GRAFTON DBM
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 Received2005-05-10
Decision Date2006-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169964952 K051188 000

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