FST CATH-UD, CATHETER— 510(k) K950908

Name: FDA 510(k) clearance K950908
Creator: U.S. Food and Drug Administration
Published: 1995-04-07

Substantially Equivalent

Fiberoptic Sensor Technlogies, Inc.

FDA 510(k) clearance K950908 for FST CATH-UD, CATHETER, Substantially Equivalent on 1995-04-07. Applicant: Fiberoptic Sensor Technlogies, Inc.. Device class: 2.

Clearance details

Applicant: Fiberoptic Sensor Technlogies, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-16
Decision date: 1995-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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