FDA 510(k) Application Details - K192035

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K192035
Device Name	Apparatus, Exhaust, Surgical
Applicant	Bio Protech, Inc. 151-3, Donghwagongdan-ro, Munmak-eup Wonju-si 200-801 KR Other 510(k) Applications for this Company
Contact	Namhyun Cho Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2019
Decision Date	08/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review