THE O'NEIL STERILE FIELD URINARY CATHETER KIT— 510(k) K002803

Name: FDA 510(k) clearance K002803
Creator: U.S. Food and Drug Administration
Published: 2000-12-27

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K002803 for THE O'NEIL STERILE FIELD URINARY CATHETER KIT, Substantially Equivalent on 2000-12-27. Applicant: Go Medical Industries Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2000-09-08
Decision date: 2000-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Subiaco, Perth, AU

Download summary PDF View on FDA.gov ↗

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