KENDALL URODYNAMIC CATHETERS— 510(k) K933399

Name: FDA 510(k) clearance K933399
Creator: U.S. Food and Drug Administration
Published: 1993-11-02

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K933399 for KENDALL URODYNAMIC CATHETERS, Substantially Equivalent on 1993-11-02. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 2.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-12
Decision date: 1993-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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