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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 K112396
Device Name IUI CATHETERS
Applicant
KITAZATO MEDICAL CO., LTD.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Applicant Contact RICHARD VINCINS
Correspondent
KITAZATO MEDICAL CO., LTD.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Correspondent Contact RICHARD VINCINS
Regulation Number884.6110
Classification Product Code
MQF  
Date Received08/19/2011
Decision Date 11/02/2012
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
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