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FDA 510(k) Application Details - K032566
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K032566
Device Name
Pump, Breast, Powered
Applicant
THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON, MA 02322 US
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ROBIN C CONNOR
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Regulation Number
884.5160
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Classification Product Code
HGX
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Date Received
08/21/2003
Decision Date
09/15/2003
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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