ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER— 510(k) K852115

Name: FDA 510(k) clearance K852115
Creator: U.S. Food and Drug Administration
Published: 1985-11-01

Substantially Equivalent

Ars Enterprises, Inc.

FDA 510(k) clearance K852115 for ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER, Substantially Equivalent on 1985-11-01. Applicant: Ars Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Ars Enterprises, Inc.
Product code: Code FLF
Device class: Class 2
Regulation: 21 CFR 880.6860
Advisory panel: General Hospital
Date received: 1985-05-15
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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