PERMANENT PACING LEAD, MODEL PY2

Permanent Pacemaker Electrode

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Permanent Pacing Lead, Model Py2.

Pre-market Notification Details

Device IDK041809
510k NumberK041809
Device Name:PERMANENT PACING LEAD, MODEL PY2
ClassificationPermanent Pacemaker Electrode
Applicant Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor,  FL  34683
ContactMila Doskocil
CorrespondentMila Doskocil
Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor,  FL  34683
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-06
Decision Date2004-08-06

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