THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS— 510(k) K011055

Name: FDA 510(k) clearance K011055
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K011055 for THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS, Substantially Equivalent on 2001-06-06. 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: 2001-04-06
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Subiaco, Perth, AU

Download summary PDF View on FDA.gov ↗

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