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FDA 510(k) Application Details - K082802
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K082802
Device Name
Pump, Breast, Powered
Applicant
LEARNING CURVE BRANDS INC. THE FIRST YEARS
100 TECHNOLOGY CTR. DR.
SUITE 2A
STOUGHTON, MA 02072 US
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Contact
SUPRAVAN KHONGKRUAPHAN
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
09/24/2008
Decision Date
10/09/2008
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
Y
Expedited Review
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