FDA 510(k) Application Details - K032301

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K032301
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant NEOGEN TECHNOLOGIES, INC
5353 NW 35TH AVE.
FT LAUDERDALE, FL 33309 US
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Contact LYDIA B BIGGIE
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 07/25/2003
Decision Date 08/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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