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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K141666
Device Name FERTILIGENT SLOW RELEASE IUI CATHETER KIT
Applicant
Fertiligent, Ltd.
5610 W. 82nd St.
Indianapolis,  IN  46278
Applicant Contact BABACAR DIOUF
Correspondent
Fertiligent, Ltd.
5610 W. 82nd St.
Indianapolis,  IN  46278
Correspondent Contact BABACAR DIOUF
Regulation Number884.6110
Classification Product Code
MQF  
Date Received06/23/2014
Decision Date 02/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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