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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 K112695
Device Name CRYOTOP
Applicant
Kitazato Biopharma Co;Ltd
611 W. 5th St.
Austin,  TX  78701
Applicant Contact RICHARD VINCINS CQA,RAC(US,EU)
Correspondent
Kitazato Biopharma Co;Ltd
611 W. 5th St.
Austin,  TX  78701
Correspondent Contact RICHARD VINCINS CQA,RAC(US,EU)
Regulation Number884.6160
Classification Product Code
MQK  
Date Received09/15/2011
Decision Date 12/12/2012
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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