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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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More FDA Info for this Product Code
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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