RAPPORT V.T.D.— 510(k) K971443

Substantially Equivalent

Owen Mumford USA, Inc.

FDA 510(k) clearance K971443 for RAPPORT V.T.D., Substantially Equivalent on 1997-09-26. Applicant: Owen Mumford USA, Inc.. Device class: 2.

Clearance details

Applicant: Owen Mumford USA, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-21
Decision date: 1997-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.