ZIP CONDOM CATHETER— 510(k) K964219

Substantially Equivalent

Goulter Medical, Inc.

FDA 510(k) clearance K964219 for ZIP CONDOM CATHETER, Substantially Equivalent on 1997-08-11. Applicant: Goulter Medical, Inc..

Clearance details

Applicant: Goulter Medical, Inc.
Product code: Code EYZ
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-22
Decision date: 1997-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.