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510(k) K953870

Device
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
Applicant
MEDTRONIC VASCULAR
510(k) number
K953870
Product code
GKN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-31
Date received
1995-08-17
Regulation
864.5400
Classification name
Timer, Clot, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES M LUMPKIN
Address
18501 E Plz. Dr. Parker CO US 80134 80134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERMedtronic Hemotec, Inc.1994-09-20
K913320MIL CM-II COAGULATION MACHINEMedical Innovations Corp.1992-06-16

Legacy Summary#

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FDA Review#

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