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FDA 510(k) Applications for Medical Device Product Code "QFC"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K223263
3M
Prevena Plus 125 Therapy Unit
02/13/2023
DEN180013
KCI USA, Inc.
PREVENA 125 and PREVENA PLUS 125 Therapy Units
04/19/2019
K203716
Smith and Nephew Medical Limited
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System
12/14/2021
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