FDA 510(k) Application Details - K193009

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K193009
Device Name	Lancet, Blood
Applicant	Promisemed Hangzhou Meditech Co., Ltd. No. 12, Longtan Road, Cangqian Street Yuhang District Hangzhou City 311121 CN Other 510(k) Applications for this Company
Contact	Zearou Yang Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2019
Decision Date	12/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review