TSO3 OZONE CHEMICAL INDICATOR— 510(k) K021161

Name: FDA 510(k) clearance K021161
Creator: U.S. Food and Drug Administration
Published: 2003-08-27

Substantially Equivalent

Technologies of Sterilization With Oxone, Tso3, Inc.

FDA 510(k) clearance K021161 for TSO3 OZONE CHEMICAL INDICATOR, Substantially Equivalent on 2003-08-27. Applicant: Technologies of Sterilization With Oxone, Tso3, Inc.. Device class: 2.

Clearance details

Applicant: Technologies of Sterilization With Oxone, Tso3, Inc.
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2002-04-11
Decision date: 2003-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairport, NY, US

Download summary PDF View on FDA.gov ↗

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