CUSTODIOL— 510(k) K032794

Substantially Equivalent

Dr. Franz Kohler Chemie GmbH

FDA 510(k) clearance K032794 for CUSTODIOL, Substantially Equivalent on 2004-04-05. Applicant: Dr. Franz Kohler Chemie GmbH. Device class: 2.

Clearance details

Applicant: Dr. Franz Kohler Chemie GmbH
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-08
Decision date: 2004-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.