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FDA 510(k) Application Details - K100385
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K100385
Device Name
Pump, Breast, Powered
Applicant
LUV N' CARE, LTD.
1705. S CAPITOL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
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Contact
JEAN ASQUITH
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
02/16/2010
Decision Date
03/24/2010
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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