KENDALL CURITY URETERAL CATHETER— 510(k) K964899

Name: FDA 510(k) clearance K964899
Creator: U.S. Food and Drug Administration
Published: 1997-02-07

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K964899 for KENDALL CURITY URETERAL CATHETER, Substantially Equivalent on 1997-02-07. 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 EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-03
Decision date: 1997-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.