VERIFY Incubator for Assert Self Contained Biological Indicators— 510(k) K163587

Name: FDA 510(k) clearance K163587
Creator: U.S. Food and Drug Administration
Published: 2017-03-24

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K163587 for VERIFY Incubator for Assert Self Contained Biological Indicators, Substantially Equivalent on 2017-03-24. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code OWP
Device class: Class 2
Regulation: 21 CFR 880.2805
Advisory panel: General Hospital
Date received: 2016-12-20
Decision date: 2017-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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