EOGas 4 Ethylene Oxide Gas Sterilizer— 510(k) K192978

Name: FDA 510(k) clearance K192978
Creator: U.S. Food and Drug Administration
Published: 2020-11-12

Substantially Equivalent

Andersen Sterilizers, Inc.

FDA 510(k) clearance K192978 for EOGas 4 Ethylene Oxide Gas Sterilizer, Substantially Equivalent on 2020-11-12. Applicant: Andersen Sterilizers, Inc.. Device class: 2.

Clearance details

Applicant: Andersen Sterilizers, Inc.
Product code: Code FLF
Device class: Class 2
Regulation: 21 CFR 880.6860
Advisory panel: General Hospital
Date received: 2019-10-24
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haw River, NC, US

Download summary PDF View on FDA.gov ↗

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