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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 K162878
Device Name Kitazato ET Catheters
Applicant
Kitazato Corporation
1-1-8 Shibadaimon, Minato-ku
Tokyo,  JP 105-0012
Applicant Contact Mari Yazaki
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number884.6110
Classification Product Code
MQF  
Date Received10/14/2016
Decision Date 07/13/2017
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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