SUPRAPUBIC CATHETER AND INTRODUCER SET— 510(k) K132890

Name: FDA 510(k) clearance K132890
Creator: U.S. Food and Drug Administration
Published: 2014-01-17

Substantially Equivalent

Mediplus , Ltd.

FDA 510(k) clearance K132890 for SUPRAPUBIC CATHETER AND INTRODUCER SET, Substantially Equivalent on 2014-01-17. Applicant: Mediplus , Ltd.. Device class: 2.

Clearance details

Applicant: Mediplus , Ltd.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 2013-09-16
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: High Wycombe, Bucks, GB

Download summary PDF View on FDA.gov ↗

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