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FDA 510(k) Application Details - K241705
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K241705
Device Name
Pump, Breast, Powered
Applicant
MilkMate Products Inc.
780 3rd Avenue
Floor 26
New York, NY 10017 US
Other 510(k) Applications for this Company
Contact
Patrice Meagher
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
06/13/2024
Decision Date
07/12/2024
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
FDA Source Information for K241705
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