FOSSA URETERAL OPEN LUMEN STENT— 510(k) K033368

Name: FDA 510(k) clearance K033368
Creator: U.S. Food and Drug Administration
Published: 2003-11-26

Substantially Equivalent

Fossa Medical, Inc.

FDA 510(k) clearance K033368 for FOSSA URETERAL OPEN LUMEN STENT, Substantially Equivalent on 2003-11-26. Applicant: Fossa Medical, Inc.. Device class: 2.

Clearance details

Applicant: Fossa Medical, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2003-10-21
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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