COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)— 510(k) K102141

Name: FDA 510(k) clearance K102141
Creator: U.S. Food and Drug Administration
Published: 2011-05-06

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K102141 for COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED), Substantially Equivalent on 2011-05-06. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2010-07-29
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.