THERMOCHEM-HT SYSTEM— 510(k) K993330

Substantially Equivalent

Hemocleanse, Inc.

FDA 510(k) clearance K993330 for THERMOCHEM-HT SYSTEM, Substantially Equivalent on 1999-12-30. Applicant: Hemocleanse, Inc.. Device class: 2.

Clearance details

Applicant: Hemocleanse, Inc.
Product code: Code MLW
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-04
Decision date: 1999-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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