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FDA 510(k) Application Details - K070435
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K070435
Device Name
Pump, Breast, Powered
Applicant
WHITTLESTONE, INC.
102 HERITAGE AVE
CASTLE ROCK, CO 80104-y US
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Contact
GLEN THIBAULT
Other 510(k) Applications for this Contact
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
02/15/2007
Decision Date
07/17/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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