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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 K140072
Device Name CRYOTOP(R) SC
Applicant
KITAZATO BIOPHARMA CO., LTD.
816 CONGRESS AVE SUITE 1400
AUSTIN,  TX  78701
Applicant Contact RICHARD VINCINS
Correspondent
KITAZATO BIOPHARMA CO., LTD.
816 CONGRESS AVE SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact RICHARD VINCINS
Regulation Number884.6160
Classification Product Code
MQK  
Date Received01/13/2014
Decision Date 04/03/2014
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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