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FDA 510(k) Application Details - K160487
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K160487
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
KCI USA, Inc.
6203 Farinon Drive
San Antonio, TX 78249 US
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Contact
Kristen Weniger Hopewell
Other 510(k) Applications for this Contact
Regulation Number
878.4780
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Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
02/22/2016
Decision Date
12/09/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Y
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