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 IDK180618
510k NumberK180618
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 Austin,  TX  78735
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-09
Decision Date2018-04-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.