CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

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 Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738.

Pre-market Notification Details

Device IDK061568
510k NumberK061568
Device Name:CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
ClassificationShunt, Central Nervous System And Components
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactJocelyn Raposo
CorrespondentJocelyn Raposo
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-06
Decision Date2006-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780518372 K061568 000
20886704040924 K061568 000
10886704040958 K061568 000
10886704040941 K061568 000
10886704040934 K061568 000
10886704040910 K061568 000
10886704040903 K061568 000

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