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FDA 510(k) Application Details - K122474
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K122474
Device Name
Pump, Breast, Powered
Applicant
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN
13417 QUIVAS ST
WESTMINSTER, CO 80234 US
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Contact
Calley Herzog
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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
08/14/2012
Decision Date
12/28/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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