MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS— 510(k) K900031

Name: FDA 510(k) clearance K900031
Creator: U.S. Food and Drug Administration
Published: 1990-03-06

Substantially Equivalent

Porges Corp.

FDA 510(k) clearance K900031 for MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS, Substantially Equivalent on 1990-03-06. Applicant: Porges Corp.. Device class: 2.

Clearance details

Applicant: Porges Corp.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-04
Decision date: 1990-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, 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.