NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC

Methyl Methacrylate For Cranioplasty

NORIAN CORP.

The following data is part of a premarket notification filed by Norian Corp. with the FDA for Norian Cranial Repair System (crs)bone Cement- 5cc Kit, Norian Cranial Repair System (crs) Bone Cement- 10cc.

Pre-market Notification Details

Device IDK973789
510k NumberK973789
Device Name:NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
ClassificationMethyl Methacrylate For Cranioplasty
Applicant NORIAN CORP. 10260 BUBB RD. Cupertino,  CA  95014 -4166
ContactSusanne T Smith
CorrespondentSusanne T Smith
NORIAN CORP. 10260 BUBB RD. Cupertino,  CA  95014 -4166
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-06
Decision Date1998-05-18
Summary:summary

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