TEX-AID BLUE— 510(k) K955856

Name: FDA 510(k) clearance K955856
Creator: U.S. Food and Drug Administration
Published: 1996-02-16

Substantially Equivalent

Laborie Medical Technologies, Ltd.

FDA 510(k) clearance K955856 for TEX-AID BLUE, Substantially Equivalent on 1996-02-16. Applicant: Laborie Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Laborie Medical Technologies, Ltd.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1995-12-26
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ont. Canada, CA

Download summary PDF View on FDA.gov ↗

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