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FDA 510(k) Application Details - K100657
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K100657
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 FARINON DRIVE
SAN ANTONIO, TX 78249 US
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Contact
MARGARET MARSH
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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
03/08/2010
Decision Date
09/17/2010
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
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