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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 K120154
Device Name INTRAUTERINE INSEMINATION (IUI) CATHETER
Applicant
CATHETER RESEARCH, INC.
5610 W 82ND ST
INDIANAPOLIS,  IN  46278
Applicant Contact BABACAR DIOUF
Correspondent
CATHETER RESEARCH, INC.
5610 W 82ND ST
INDIANAPOLIS,  IN  46278
Correspondent Contact BABACAR DIOUF
Regulation Number884.6110
Classification Product Code
MQF  
Date Received01/18/2012
Decision Date 03/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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