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510(k) K913919

Device
UNIVERSAL TERMINAL CAP, 3.2MM
Applicant
TELECTRONICS PACING SYSTEMS, INC.
510(k) number
K913919
Product code
KFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-31
Date received
1991-09-03
Regulation
870.3710
Classification name
Materials, Repair Or Replacement, Pacemaker
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DUANE A SCHULTZ
Address
7400 S. Tucson Way Englewood CO US 80112 80112

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852236MEDTRONIC MODEL 5867-1AMedtronic Vascular1985-07-11
K813518IMPLANT AID SPLICING CRIMP & SLEEVEIntermedics, Inc.1982-01-12

Legacy Summary#

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FDA Review#

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