NUMED BALLOON PACING CATHETER

Electrode, Pacemaker, Temporary

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Pacing Catheter.

Pre-market Notification Details

Device IDK843290
510k NumberK843290
Device Name:NUMED BALLOON PACING CATHETER
ClassificationElectrode, Pacemaker, Temporary
Applicant NUMED, INC. MAIN ST. Hopkinton,  NY  12940
ContactAllen J Tower
CorrespondentAllen J Tower
NUMED, INC. MAIN ST. Hopkinton,  NY  12940
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-21
Decision Date1985-01-14

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