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510(k) K913320

Device
MIL CM-II COAGULATION MACHINE
Applicant
MEDICAL INNOVATIONS CORP.
510(k) number
K913320
Product code
GKN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-16
Date received
1991-07-25
Regulation
864.5400
Classification name
Timer, Clot, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND CHAN
Address
13-B, Edward Mansion 141 Prince Edward Rd. Kowloon, Hong Kong HK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953870ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTSMedtronic Vascular1995-10-31
K940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERMedtronic Hemotec, Inc.1994-09-20

Legacy Summary#

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FDA Review#

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