FDA 510(k) Application Details - K190105

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K190105
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	Taiwan Biomaterial Co., Ltd. 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei 30261 TW Other 510(k) Applications for this Company
Contact	Monoj Mon Kalita Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2019
Decision Date	02/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review