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FDA 510(k) Application Details - K152163
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K152163
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG, FL 33716 US
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Contact
Laura Reynolds
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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
08/03/2015
Decision Date
09/29/2016
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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