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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 K162051
Device Name Cryotec
Applicant
REPROLIFE INC.
2-5-5-8F, SHINJUKU
SHINJUKU-KU,  JP 160-0022
Applicant Contact KOICHI TAKEDA
Correspondent
EMERGO GROUP
816 CONGRESS AVENUE, SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact DIANE SUDDUTH
Regulation Number884.6160
Classification Product Code
MQK  
Date Received07/25/2016
Decision Date 12/14/2016
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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