LEAD TERMINAL PIN CAPS, VARIOUS MODELS

Pacemaker Lead Adaptor

BIOTRONIK, GMBH & CO.

The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Lead Terminal Pin Caps, Various Models.

Pre-market Notification Details

Device IDK911142
510k NumberK911142
Device Name:LEAD TERMINAL PIN CAPS, VARIOUS MODELS
ClassificationPacemaker Lead Adaptor
Applicant BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego,  OR  97035 -5369
ContactScott J Mindrebo
CorrespondentScott J Mindrebo
BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego,  OR  97035 -5369
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-14
Decision Date1991-08-09

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