HEPACRON PUREAIR-ZONE SYSTEM— 510(k) K862432

Substantially Equivalent

Hepacron, Inc.

FDA 510(k) clearance K862432 for HEPACRON PUREAIR-ZONE SYSTEM, Substantially Equivalent on 1986-10-16. Applicant: Hepacron, Inc.. Device class: 2.

Clearance details

Applicant: Hepacron, Inc.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 1986-06-26
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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