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510(k) K831926

Device
IMPLANTABLE ENDOCARDIAL PACING LEADS
Applicant
Oscor Inc.
510(k) number
K831926
Product code
DTG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-12
Date received
1983-06-15
Regulation
870.3690
Classification name
Magnet, Test, Pacemaker
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
3816 Desoto Blvd. Palm Harbor FL US 34683 34683

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092364MODEL 220 PATIENT MAGNETCyberonics, Inc.2009-11-03
K960849MAGNO ALARMCardiac Assist Devices, Inc.1997-03-26
K895110MAESTRO PACEMAKER TEST MAGNETCardiac Control Systems, Inc.1989-09-26
K813153TEST MAGNETPacesetter Systems1981-12-02

Legacy Summary#

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FDA Review#

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