PICO Single Use Negative Pressure Wound Therapy System

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 Single Use Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK172521
510k NumberK172521
Device Name:PICO Single Use Negative Pressure Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Smith & Nephew Medical Limited 101 Hessle Road Hull,  GB Hu3 2bn
ContactSamantha Neilson
CorrespondentSamantha Neilson
Smith & Nephew Medical Limited 101 Hessle Road Hull,  GB Hu3 2bn
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-21
Decision Date2017-09-20
Summary:summary

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