URETHRO CATHETERIZATION TRAY— 510(k) K780879

Name: FDA 510(k) clearance K780879
Creator: U.S. Food and Drug Administration
Published: 1978-07-31

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K780879 for URETHRO CATHETERIZATION TRAY, Substantially Equivalent on 1978-07-31. Applicant: Abco Dealers, Inc.. Device class: 2.

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1978-05-30
Decision date: 1978-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.