CODMAN DURAFORM DURAL GRAFT IMPLANT

Dura Substitute

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Duraform Dural Graft Implant.

Pre-market Notification Details

Device IDK041518
510k NumberK041518
Device Name:CODMAN DURAFORM DURAL GRAFT IMPLANT
ClassificationDura Substitute
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactElizabeth Dolan
CorrespondentElizabeth Dolan
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-07
Decision Date2004-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704036746 K041518 000
20886704036736 K041518 000
10886704036722 K041518 000
20886704036712 K041518 000
10886704036708 K041518 000
20886704036699 K041518 000
10886704036685 K041518 000
20886704036675 K041518 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.