CODMAN BACTISEAL EVD CATHETER SET

Shunt, Central Nervous System And Components

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Bactiseal Evd Catheter Set.

Pre-market Notification Details

Device IDK021653
510k NumberK021653
Device Name:CODMAN BACTISEAL EVD CATHETER SET
ClassificationShunt, Central Nervous System And Components
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactKathy Wunder
CorrespondentKathy Wunder
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-20
Decision Date2002-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780525363 K021653 000
10886704047049 K021653 000
10886704040965 K021653 000

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