MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER— 510(k) K031617

Name: FDA 510(k) clearance K031617
Creator: U.S. Food and Drug Administration
Published: 2004-01-16

Substantially Equivalent

Mediplus , Ltd.

FDA 510(k) clearance K031617 for MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER, Substantially Equivalent on 2004-01-16. Applicant: Mediplus , Ltd.. Device class: 2.

Clearance details

Applicant: Mediplus , Ltd.
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2003-05-23
Decision date: 2004-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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