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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 K131491
Device Name KITAZATO IUI CATHETER
Applicant
KITAZATO MEDICAL CO., LTD.
816 CONGRESS AVE. STE. 1400
AUSTIN,  TX  78701
Applicant Contact RICHARD VINCINS, CBA, CQA, RAC
Correspondent
KITAZATO MEDICAL CO., LTD.
816 CONGRESS AVE. STE. 1400
AUSTIN,  TX  78701
Correspondent Contact RICHARD VINCINS, CBA, CQA, RAC
Regulation Number884.6110
Classification Product Code
MQF  
Date Received05/23/2013
Decision Date 09/11/2013
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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