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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 K171748
Device Name Vitrification Kit and Thawing Kit
Applicant
Kitazato Corporation
81 Nakajima
Fuji,  JP 416-0907
Applicant Contact Futoshi Inoue
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Diane Sudduth
Regulation Number884.6180
Classification Product Code
MQL  
Subsequent Product Code
MQK  
Date Received06/13/2017
Decision Date 12/14/2017
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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