CUSTODIOL— 510(k) K992209

Substantially Equivalent

Dr. Franz Kohler Chemie GmbH

FDA 510(k) clearance K992209 for CUSTODIOL, Substantially Equivalent on 1999-12-10. Applicant: Dr. Franz Kohler Chemie GmbH. Device class: 2.

Clearance details

Applicant: Dr. Franz Kohler Chemie GmbH
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-30
Decision date: 1999-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, 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.