ERBEFLO 2 DISPOSABLE TUBING SYSTEM— 510(k) K103235

Name: FDA 510(k) clearance K103235
Creator: U.S. Food and Drug Administration
Published: 2010-12-23

Substantially Equivalent

Erbe USA, Inc.

FDA 510(k) clearance K103235 for ERBEFLO 2 DISPOSABLE TUBING SYSTEM, Substantially Equivalent on 2010-12-23. Applicant: Erbe USA, Inc.. Device class: 2.

Clearance details

Applicant: Erbe USA, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-02
Decision date: 2010-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.