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FDA 510(k) Application Details - K172521
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K172521
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Smith & Nephew Medical Limited
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
08/21/2017
Decision Date
09/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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