HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM

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 Holter In-line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-flo Connectors; Accu-flo Three Way Connector; Codm.

Pre-market Notification Details

Device IDK102961
510k NumberK102961
Device Name:HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
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 Received2010-10-05
Decision Date2011-02-18
Summary:summary

NIH GUDID Devices

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