FERTILIGENT SLOW RELEASE IUI CATHETER KIT— 510(k) K141666

Name: FDA 510(k) clearance K141666
Creator: U.S. Food and Drug Administration
Published: 2015-02-03

Substantially Equivalent

Fertiligent, Ltd.

FDA 510(k) clearance K141666 for FERTILIGENT SLOW RELEASE IUI CATHETER KIT, Substantially Equivalent on 2015-02-03. Applicant: Fertiligent, Ltd.. Device class: 2.

Clearance details

Applicant: Fertiligent, Ltd.
Product code: Code MQF
Device class: Class 2
Regulation: 21 CFR 884.6110
Advisory panel: Obstetrics/Gynecology
Date received: 2014-06-23
Decision date: 2015-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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