FDA 510(k) Application Details - K071301

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K071301
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant INNOVATIVE THERAPIES, INC.
11 VENDUE COURT
SIMPSONVILLE, SC 29681 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 05/09/2007
Decision Date 05/24/2007
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 Y
Expedited Review



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