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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media, reproductive
510(k) Number K190199
Device Name SepaSperm Washing Solution, SepaSperm Solution
Kitazato Corporation
81 Nakajima
Fuji-shi,  JP 416-0907
Applicant Contact Futoshi Inoue
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number884.6180
Classification Product Code
Date Received02/04/2019
Decision Date 09/26/2019
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