AN85/AN86 EO Indicators— 510(k) K150644

Name: FDA 510(k) clearance K150644
Creator: U.S. Food and Drug Administration
Published: 2015-11-18

Substantially Equivalent

Andersen Sterilizers, Inc.

FDA 510(k) clearance K150644 for AN85/AN86 EO Indicators, Substantially Equivalent on 2015-11-18. Applicant: Andersen Sterilizers, Inc.. Device class: 2.

Clearance details

Applicant: Andersen Sterilizers, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2015-03-12
Decision date: 2015-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haw River, NC, 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.