FDA 510(k) Application Details - K063692

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K063692
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO, TX 78230-4726 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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Date Received 12/13/2006
Decision Date 06/07/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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