CYBERREN— 510(k) K970989

Substantially Equivalent

Cybernius Medical , Ltd.

FDA 510(k) clearance K970989 for CYBERREN, Substantially Equivalent on 1997-07-24. Applicant: Cybernius Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Cybernius Medical , Ltd.
Product code: Code KPF
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-18
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Albert, Alberta, CA

Download summary PDF View on FDA.gov ↗

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