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FDA 510(k) Application Details - K112695
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K112695
Device Name
Labware, Assisted Reproduction
Applicant
KITAZATO BIOPHARMA CO;LTD
611 WEST 5TH ST
AUSTIN, TX 78701 US
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Contact
RICHARD VINCINS CQA,RAC(US,EU)
Other 510(k) Applications for this Contact
Regulation Number
884.6160
More FDA Info for this Regulation Number
Classification Product Code
MQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2011
Decision Date
12/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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