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FDA 510(k) Application Details - K151436
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K151436
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
SMITH & NEPHEW MEDICAL LTD
101 HESSLE ROAD
HULL HU3 2BN GB
Other 510(k) Applications for this Company
Contact
SAMANTHA NEILSON
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
OMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2015
Decision Date
01/28/2016
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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