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FDA 510(k) Application Details - K142385
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K142385
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Wound RX Medical, LLC
25 Depot Hill Road
Building One, Ste 104
Southbury, CT 06488 US
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Contact
Richard Deslauriers
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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
08/27/2014
Decision Date
05/22/2015
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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