ELECTRODE, TEMPORARY MYOCARDIAL

Permanent Pacemaker Electrode

WINN HIRSCH & ASSOC.

The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Electrode, Temporary Myocardial.

Pre-market Notification Details

Device IDK760513
510k NumberK760513
Device Name:ELECTRODE, TEMPORARY MYOCARDIAL
ClassificationPermanent Pacemaker Electrode
Applicant WINN HIRSCH & ASSOC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-25
Decision Date1976-10-15

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