SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System— 510(k) K190104

Name: FDA 510(k) clearance K190104
Creator: U.S. Food and Drug Administration
Published: 2019-03-22

Substantially Equivalent

Steris Corporations

FDA 510(k) clearance K190104 for SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Substantially Equivalent on 2019-03-22. Applicant: Steris Corporations. Device class: 2.

Clearance details

Applicant: Steris Corporations
Product code: Code MED
Device class: Class 2
Regulation: 21 CFR 880.6885
Advisory panel: General Hospital
Date received: 2019-01-22
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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