LUMAX CYSTOMETRY ADMINISTRATION TUBE SET— 510(k) K971911

Name: FDA 510(k) clearance K971911
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent

Medamicus, Inc.

FDA 510(k) clearance K971911 for LUMAX CYSTOMETRY ADMINISTRATION TUBE SET, Substantially Equivalent on 1997-06-03. Applicant: Medamicus, Inc.. Device class: 2.

Clearance details

Applicant: Medamicus, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-28
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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