PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS— 510(k) K051711

Name: FDA 510(k) clearance K051711
Creator: U.S. Food and Drug Administration
Published: 2005-11-15

Substantially Equivalent

Denver Biomedical, Inc.

FDA 510(k) clearance K051711 for PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS, Substantially Equivalent on 2005-11-15. Applicant: Denver Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Denver Biomedical, Inc.
Product code: Code PNG
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-27
Decision date: 2005-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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