LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY— 510(k) K073552

Name: FDA 510(k) clearance K073552
Creator: U.S. Food and Drug Administration
Published: 2008-03-05

Substantially Equivalent

Laborie Medical Technologies, Corp.

FDA 510(k) clearance K073552 for LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY, Substantially Equivalent on 2008-03-05. Applicant: Laborie Medical Technologies, Corp.. Device class: 2.

Clearance details

Applicant: Laborie Medical Technologies, Corp.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2007-12-18
Decision date: 2008-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williston, VT, US

Download summary PDF View on FDA.gov ↗

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