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FDA 510(k) Application Details - K202862
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K202862
Device Name
Media, Reproductive
Applicant
Vitrolife Sweden AB
Gustaf Werners gata 2
Vastra Frolunda 42132 SE
Other 510(k) Applications for this Company
Contact
Sarah Hood Hagberg
Other 510(k) Applications for this Contact
Regulation Number
884.6180
More FDA Info for this Regulation Number
Classification Product Code
MQL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2020
Decision Date
05/14/2021
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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