MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL

Automated External Defibrillators (non-wearable)

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Combination Defibrillation & Ecg Electrode For Laerdal.

Pre-market Notification Details

Device IDK955923
510k NumberK955923
Device Name:MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
ClassificationAutomated External Defibrillators (non-wearable)
Applicant GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo,  NY  14240 -1271
ContactKathleen Selover
CorrespondentKathleen Selover
GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo,  NY  14240 -1271
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-28
Decision Date1996-10-24
Summary:summary

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