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510(k) K813518

Device
IMPLANT AID SPLICING CRIMP & SLEEVE
Applicant
INTERMEDICS, INC.
510(k) number
K813518
Product code
KFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-12
Date received
1981-12-16
Regulation
870.3710
Classification name
Materials, Repair Or Replacement, Pacemaker
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913919UNIVERSAL TERMINAL CAP, 3.2MMTelectronics Pacing Systems, Inc.1991-12-31
K852236MEDTRONIC MODEL 5867-1AMedtronic Vascular1985-07-11

Legacy Summary#

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FDA Review#

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