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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 K160864
Device Name Cryotop Vitrification Kit and Cryotop Thawing Kit
Applicant
Kitazato Biopharma Co., Ltd.
81 Nakijima
Fuji,  JP 416-0907
Applicant Contact FUTOSHI INOUE
Correspondent
Emergo Global Consulting, LLC
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact RICHARD VINCINS
Regulation Number884.6180
Classification Product Code
MQL  
Subsequent Product Code
MQK  
Date Received03/29/2016
Decision Date 10/07/2016
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 Yes
Predetermined Change
Control Plan Authorized		 No
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