gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)— 510(k) K163144

Name: FDA 510(k) clearance K163144
Creator: U.S. Food and Drug Administration
Published: 2017-04-07

Substantially Equivalent

Gke-GmbH

FDA 510(k) clearance K163144 for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI), Substantially Equivalent on 2017-04-07. Applicant: Gke-GmbH. Device class: 2.

Clearance details

Applicant: Gke-GmbH
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2016-11-09
Decision date: 2017-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waldems, DE

Download summary PDF View on FDA.gov ↗

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