PICO Single Use Negative Pressure Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

SMITH & NEPHEW MEDICAL LTD

The following data is part of a premarket notification filed by Smith & Nephew Medical Ltd with the FDA for Pico Single Use Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK151436
510k NumberK151436
Device Name:PICO Single Use Negative Pressure Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant SMITH & NEPHEW MEDICAL LTD 101 HESSLE ROAD Hull,  GB Hu3 2bn
ContactSamantha Neilson
CorrespondentSamantha Neilson
SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St Petersburg,  FL  33716
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-28
Decision Date2016-01-28
Summary:summary

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