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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K123258
Device Name THE ADVANCE CATHETER FOR HSG AND SIS
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 Number884.4530
Classification Product Code
LKF  
Date Received10/18/2012
Decision Date 01/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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