MODEL KY PACEMAKER LEAD - VARIOUS

Permanent Pacemaker Electrode

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Model Ky Pacemaker Lead - Various.

Pre-market Notification Details

Device IDK823891
510k NumberK823891
Device Name:MODEL KY PACEMAKER LEAD - VARIOUS
ClassificationPermanent Pacemaker Electrode
Applicant Oscor Inc. 3816 DeSoto Blvd. Palm Harbor,  FL  34683
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-27
Decision Date1983-03-31

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