HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.— 510(k) K894317

Name: FDA 510(k) clearance K894317
Creator: U.S. Food and Drug Administration
Published: 1989-09-05

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K894317 for HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS., Substantially Equivalent on 1989-09-05. Applicant: Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Hemotec, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 1989-07-14
Decision date: 1989-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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