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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name labware, assisted reproduction
510(k) Number K153027
Device Name Cryotop US
Applicant
KITAZATO BIOPHARMA CO., LTD.
81 Nakajima
FUJI,  JP 416-0907
Applicant Contact FUTOSHI INOUE
Correspondent
EMERGO GLOBAL CONSULTING, LLC
816 CONGRESS AVENUE
SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact RICHARD VINCINS
Regulation Number884.6160
Classification Product Code
MQK  
Date Received10/16/2015
Decision Date 03/14/2016
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 No
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