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510(k) K953870

ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS by Medtronic Vascular — Product Code GKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1995
Date Received
August 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Timer, Clot, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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