IMPLANTABLE CARDIAC PACING LEADS

Permanent Pacemaker Electrode

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Implantable Cardiac Pacing Leads.

Pre-market Notification Details

Device IDK831767
510k NumberK831767
Device Name:IMPLANTABLE CARDIAC PACING LEADS
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 Received1983-06-01
Decision Date1983-07-26

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