BK-N SEALING CAP

Pacemaker Lead Adaptor

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Bk-n Sealing Cap.

Pre-market Notification Details

Device IDK971930
510k NumberK971930
Device Name:BK-N SEALING CAP
ClassificationPacemaker Lead Adaptor
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactKenneth Jensen
CorrespondentKenneth Jensen
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSe Subject To Traking & Pms (PT)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-27
Decision Date1997-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04035479000974 K971930 000

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