FDA 510(k) Application Details - K032310

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K032310
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO, TX 78216-9508 US
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Contact JUDITH HARBOUR
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 07/28/2003
Decision Date 10/10/2003
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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