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
00382830050579 K061568 000
00382830050609 K061568 000
00382830050616 K061568 000
10886704040903 K061568 000
10886704040910 K061568 000
10886704040934 K061568 000
10886704040941 K061568 000
10886704040958 K061568 000
20886704040924 K061568 000
00382830050562 K061568 000

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