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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 Ave. 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
Predetermined Change
Control Plan Authorized		 No
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