HEPCON/SYSTEM RC-10— 510(k) K800161

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K800161 for HEPCON/SYSTEM RC-10, Substantially Equivalent on 1980-03-19. 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: 1980-01-24
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.