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FDA 510(k) Application Details - K063590
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K063590
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO, TX 78230-4726 US
Other 510(k) Applications for this Company
Contact
CHRISTY HUBBARD OVIATT
Other 510(k) Applications for this Contact
Regulation Number
878.4780
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Classification Product Code
OMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2006
Decision Date
01/25/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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