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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 K181469
Device Name Cryotop®US-flash and Cryotop®US-scoop
Applicant
Kitazato Corporation
81 Nakajima
Fuji-Shi,  JP 416-0907
Applicant Contact Futoshi Inoue
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Diane Sudduth
Regulation Number884.6160
Classification Product Code
MQK  
Date Received06/04/2018
Decision Date 11/09/2018
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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