GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER— 510(k) K093904

Name: FDA 510(k) clearance K093904
Creator: U.S. Food and Drug Administration
Published: 2010-04-14

Substantially Equivalent

Glenveigh Surgical, LLC

FDA 510(k) clearance K093904 for GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER, Substantially Equivalent on 2010-04-14. Applicant: Glenveigh Surgical, LLC. Device class: 2.

Clearance details

Applicant: Glenveigh Surgical, LLC
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2009-12-22
Decision date: 2010-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swanee, GA, US

Download summary PDF View on FDA.gov ↗

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