RUSCH URODYNAMIC RECTAL BALLOON CATHETER— 510(k) K952573

Name: FDA 510(k) clearance K952573
Creator: U.S. Food and Drug Administration
Published: 1995-06-15

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K952573 for RUSCH URODYNAMIC RECTAL BALLOON CATHETER, Substantially Equivalent on 1995-06-15. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-05
Decision date: 1995-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, 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.