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FDA 510(k) Application Details - K200712
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K200712
Device Name
Pump, Breast, Powered
Applicant
A Cute Baby, Inc.
865 N 1430 W
Orem, UT 84057 US
Other 510(k) Applications for this Company
Contact
Matthew Kho
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/2020
Decision Date
04/17/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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