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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719745008306 K193185 000
04719745008184 K193185 000
04719745008191 K193185 000
04719745008207 K193185 000
04719745008214 K193185 000
04719745008221 K193185 000
04719745008252 K193185 000
04719745008269 K193185 000
04719745008276 K193185 000
04719745008283 K193185 000
04719745008290 K193185 000
04719745008177 K193185 000

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