MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER— 510(k) K901603

Name: FDA 510(k) clearance K901603
Creator: U.S. Food and Drug Administration
Published: 1990-05-04

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K901603 for MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER, Substantially Equivalent on 1990-05-04. Applicant: Bivona Medical Technologies. Device class: 2.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-27
Decision date: 1990-05-04
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.