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FDA 510(k) Application Details - K181937
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K181937
Device Name
Pump, Breast, Powered
Applicant
Medela LLC
1101 Corporate Drive
McHenry, IL 60050 US
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Contact
PJ Pasia
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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
07/19/2018
Decision Date
10/16/2018
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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