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FDA 510(k) Application Details - K102600
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K102600
Device Name
Pump, Breast, Powered
Applicant
EVENFLO COMPANY, INC.
225 BYERS RD.
MIAMISBURG, OH 45342 US
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Contact
AMY NEFF
Other 510(k) Applications for this Contact
Regulation Number
884.5160
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Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2010
Decision Date
12/22/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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