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510(k) K070926

Device
ELECTRODE/EXTENSION CABLES, MODELS ATAR
Applicant
Oscor Inc.
510(k) number
K070926
Product code
IKD  
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-07
Date received
2007-04-03
Regulation
890.1175
Classification name
Cable, Electrode
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MILA DOSKOCIL
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 IKD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992372THE LEADAWAYTherapy Equipment, Inc.1999-10-13
K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONPhysiometrix, Inc.1993-12-23
K873361LIFE-SPAN CABLEChemfet Corp.1987-11-09
K834583CLEAR LEADS-RADIOTRANSPARENT WIRESQuinton, Inc.1984-01-30
K800934R2 ESU CABLE-ADAPTER MODELS 160,161R2 Corp.1980-05-20

Legacy Summary#

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FDA Review#

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