Chemical Indicator for Steam— 510(k) K220778

Name: FDA 510(k) clearance K220778
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Substantially Equivalent

True Indicating, LLC

FDA 510(k) clearance K220778 for Chemical Indicator for Steam, Substantially Equivalent on 2022-12-02. Applicant: True Indicating, LLC. Device class: 2.

Clearance details

Applicant: True Indicating, LLC
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2022-03-17
Decision date: 2022-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, 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.