CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT— 510(k) K020205

Name: FDA 510(k) clearance K020205
Creator: U.S. Food and Drug Administration
Published: 2002-06-24

Substantially Equivalent

Getinge/Castle, Inc.

FDA 510(k) clearance K020205 for CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT, Substantially Equivalent on 2002-06-24. Applicant: Getinge/Castle, Inc.. Device class: 2.

Clearance details

Applicant: Getinge/Castle, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2002-01-22
Decision date: 2002-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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