U-TEX— 510(k) K955810

Substantially Equivalent

Laborie Medical Technologies, Ltd.

FDA 510(k) clearance K955810 for U-TEX, Substantially Equivalent on 1996-01-24. Applicant: Laborie Medical Technologies, Ltd.. Device class: 1.

Clearance details

Applicant: Laborie Medical Technologies, Ltd.
Product code: Code FHA
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1995-12-26
Decision date: 1996-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.