Name: Predicase
Price: 199 USD

K-number	K953870
Device name	ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
Applicant	Medtronic Vascular
Product code	GKN
Device class	Class II
Decision date	Oct 31, 1995
Decision	Substantially Equivalent
Regulation	864.5400

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Source

View the full FDA submission: accessdata.fda.gov

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ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS

Everything you need for a 510(k) submission. Nothing you don't.