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FDA 510(k) Application Details - K210936
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K210936
Device Name
Pump, Breast, Powered
Applicant
Chiaro Technology Limited
2nd Floor 63-66 Hatton Garden
London EC1N 8LE GB
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Contact
Carre King
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Regulation Number
884.5160
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Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
03/29/2021
Decision Date
08/25/2021
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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