Quiver Laparoscopic Extendable— 510(k) K153472

Name: FDA 510(k) clearance K153472
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Substantially Equivalent

Itl Corporation Pty, Ltd.

FDA 510(k) clearance K153472 for Quiver Laparoscopic Extendable, Substantially Equivalent on 2016-06-23. Applicant: Itl Corporation Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Itl Corporation Pty, Ltd.
Product code: Code HAM
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2015-12-02
Decision date: 2016-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea Heights, Vic, AU

Download summary PDF View on FDA.gov ↗

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