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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
Predetermined Change
Control Plan Authorized		 No
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