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FDA 510(k) Application Details - K162051
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K162051
Device Name
Labware, Assisted Reproduction
Applicant
REPROLIFE INC.
2-5-5-8F, SHINJUKU
SHINJUKU-KU 160-0022 JP
Other 510(k) Applications for this Company
Contact
KOICHI TAKEDA
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
07/25/2016
Decision Date
12/14/2016
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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