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FDA 510(k) Application Details - K133276
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K133276
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO, TX 78249 US
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Contact
MELANIE AVILA
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
10/24/2013
Decision Date
11/19/2013
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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