SUPRAPUBIC FLOW CONTROLLER— 510(k) K904798

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K904798 for SUPRAPUBIC FLOW CONTROLLER, Substantially Equivalent on 1991-11-22. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-24
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, 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.