SYSTEM 1E CHEMICAL INDICATOR— 510(k) K102217

Name: FDA 510(k) clearance K102217
Creator: U.S. Food and Drug Administration
Published: 2010-11-22

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K102217 for SYSTEM 1E CHEMICAL INDICATOR, Substantially Equivalent on 2010-11-22. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2010-08-06
Decision date: 2010-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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