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FDA 510(k) Application Details - K212426
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K212426
Device Name
Media, Reproductive
Applicant
DonneVie Medical Technology (Shanghai) Co. Ltd.
Suite 201, Bld 1, 138 Xinjun Ring
Shanghai 201114 CN
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Contact
Hannah Hang Yin
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
08/04/2021
Decision Date
06/16/2022
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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