CORRESTORE PATCH SYSTEM

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

SOMANETICS CORP.

The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Correstore Patch System.

Pre-market Notification Details

Device IDK040162
510k NumberK040162
Device Name:CORRESTORE PATCH SYSTEM
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant SOMANETICS CORP. 1653 EAST MAPLE RD. Troy,  MI  48083 -4208
ContactRonald A Widman
CorrespondentRonald A Widman
SOMANETICS CORP. 1653 EAST MAPLE RD. Troy,  MI  48083 -4208
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-26
Decision Date2004-03-16
Summary:summary

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