FDA 510(k) Application Details - K193185

Device Classification Name	More FDA Info for this Device
510(K) Number	K193185
Device Name	Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
Applicant	BenQ Materials Corporation No, 29, Jianguo E. Rd., Gueishan Taoyuan 33341 TW Other 510(k) Applications for this Company
Contact	Miranda Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2019
Decision Date	05/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review