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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 K192540
Device Name Kitazato ET Catheters
Applicant
Kitazato Corporation
Shibakoen Bldg., 1-1-8 Shibadaimon, Minato-Ku
Tokyo,  JP 105-0012
Applicant Contact Futoshi Inoue
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number884.6110
Classification Product Code
MQF  
Date Received09/16/2019
Decision Date 05/01/2020
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
Predetermined Change
Control Plan Authorized		 No
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