CART, MODE NUMBER UDS-CART— 510(k) K950016

Name: FDA 510(k) clearance K950016
Creator: U.S. Food and Drug Administration
Published: 1995-03-30

Substantially Equivalent

Laborie Medical Tech Corp.

FDA 510(k) clearance K950016 for CART, MODE NUMBER UDS-CART, Substantially Equivalent on 1995-03-30. Applicant: Laborie Medical Tech Corp.. Device class: 2.

Clearance details

Applicant: Laborie Medical Tech Corp.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-03
Decision date: 1995-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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