RB12 SUCTION RECTAL BIOPSY SYSTEM— 510(k) K062159

Name: FDA 510(k) clearance K062159
Creator: U.S. Food and Drug Administration
Published: 2006-09-05

Substantially Equivalent

Aus Systems Pty , Ltd.

FDA 510(k) clearance K062159 for RB12 SUCTION RECTAL BIOPSY SYSTEM, Substantially Equivalent on 2006-09-05. Applicant: Aus Systems Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Aus Systems Pty , Ltd.
Product code: Code FCK
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2006-07-28
Decision date: 2006-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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