SLIP UROLOGY INTRODUCER SHEATH— 510(k) K040520

Name: FDA 510(k) clearance K040520
Creator: U.S. Food and Drug Administration
Published: 2004-05-20

Substantially Equivalent

Percutaneous Systems, Inc.

FDA 510(k) clearance K040520 for SLIP UROLOGY INTRODUCER SHEATH, Substantially Equivalent on 2004-05-20. Applicant: Percutaneous Systems, Inc.. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-27
Decision date: 2004-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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