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FDA 510(k) Application Details - K212955
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K212955
Device Name
Pump, Breast, Powered
Applicant
Hygeia II Medical Group, Inc.
6241 Yarrow Drive
Carlsbad, CA 92011 US
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Contact
Brett Nakfoor
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
09/16/2021
Decision Date
03/15/2022
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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