Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

Negative Pressure Wound Therapy Non-powered Suction Apparatus

BenQ Materials Corporation

The following data is part of a premarket notification filed by Benq Materials Corporation with the FDA for Anscare Simo Negative Pressure Wound Therapy (npwt) System.

Pre-market Notification Details

Device IDK193185
510k NumberK193185
Device Name:Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
ClassificationNegative Pressure Wound Therapy Non-powered Suction Apparatus
Applicant BenQ Materials Corporation No, 29, Jianguo E. Rd., Gueishan Taoyuan,  TW 33341
ContactMiranda Chang
CorrespondentIsabel Tsai
BenQ Materials Corporation 29 Jianguo E. Rd., Guishan Taoyuan,  TW 33341
Product CodeOKO  
CFR Regulation Number878.4683 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-05-04

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