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 IDK180614
510k NumberK180614
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
ContactLavinia Tompkins
CorrespondentKulsum Master
Smith & Nephew 7000 West William Cannon Drive Austin,  TX  78735
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-08
Decision Date2018-04-06
Summary:summary

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