CAP BONE SUBSTITUTE MATERIAL

Methyl Methacrylate For Cranioplasty

ETEX CORP.

The following data is part of a premarket notification filed by Etex Corp. with the FDA for Cap Bone Substitute Material.

Pre-market Notification Details

Device IDK032307
510k NumberK032307
Device Name:CAP BONE SUBSTITUTE MATERIAL
ClassificationMethyl Methacrylate For Cranioplasty
Applicant ETEX CORP. UNIVERSITY PARK AT MIT 38 SIDNEY STREET Cambridge,  MA  02139
ContactKristine Canavan
CorrespondentKristine Canavan
ETEX CORP. UNIVERSITY PARK AT MIT 38 SIDNEY STREET Cambridge,  MA  02139
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-25
Decision Date2003-10-24
Summary:summary

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