CLOTTRAC COAGULATION CONTROL— 510(k) K923594

Name: FDA 510(k) clearance K923594
Creator: U.S. Food and Drug Administration
Published: 1992-09-21

Substantially Equivalent

Medtronic Hemotec, Inc.

FDA 510(k) clearance K923594 for CLOTTRAC COAGULATION CONTROL, Substantially Equivalent on 1992-09-21. Applicant: Medtronic Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Hemotec, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1992-07-20
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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