BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM

Filler, Bone Void, Calcium Compound

BERKELEY ADVANCED BIOMATERIALS, INC.

The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Bi-ostetic Foam, Cem-ostetic Foam, Tri-ostetic Foam, Generos Foam.

Pre-market Notification Details

Device IDK053213
510k NumberK053213
Device Name:BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
ClassificationFiller, Bone Void, Calcium Compound
Applicant BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley,  CA  94710
ContactFrancois Genin
CorrespondentFrancois Genin
BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley,  CA  94710
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-16
Decision Date2006-07-06
Summary:summary

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