KITAZATO IUI CATHETER— 510(k) K131491

Name: FDA 510(k) clearance K131491
Creator: U.S. Food and Drug Administration
Published: 2013-09-11

Substantially Equivalent

Kitazato Medical Co., Ltd.

FDA 510(k) clearance K131491 for KITAZATO IUI CATHETER, Substantially Equivalent on 2013-09-11. Applicant: Kitazato Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kitazato Medical Co., Ltd.
Product code: Code MQF
Device class: Class 2
Regulation: 21 CFR 884.6110
Advisory panel: Obstetrics/Gynecology
Date received: 2013-05-23
Decision date: 2013-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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