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, PICO Fluid Management Pack

Negative Pressure Wound Therapy Powered Suction Pump

Smith & Nephew Medical Limited

The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for 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, Pico Fluid Management Pack.

Pre-market Notification Details

Device IDK202157
510k NumberK202157
Device Name: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, PICO Fluid Management Pack
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Smith & Nephew Medical Limited 101 Hessle Road Hull,  GB Hu3 2bn
ContactSteeve Lamvohee
CorrespondentSteeve Lamvohee
Smith & Nephew Medical Limited 101 Hessle Road Hull,  GB Hu3 2bn
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2020-10-30

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