FST COUNCIL TIP FOLEY CATHETER— 510(k) K922776

Name: FDA 510(k) clearance K922776
Creator: U.S. Food and Drug Administration
Published: 1993-07-20

Substantially Equivalent

Fiberoptic Sensor Technlogies, Inc.

FDA 510(k) clearance K922776 for FST COUNCIL TIP FOLEY CATHETER, Substantially Equivalent on 1993-07-20. 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: 1992-06-09
Decision date: 1993-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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