FDA 510(k) Application Details - K191853

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K191853
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Promisemed Hangzhou Meditech Co., Ltd. Bldg. 1, No. 12, Longtan Road, Cangqian Street Yuhang District Hangzhou City CN Other 510(k) Applications for this Company
Contact	Zearou Yang Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2019
Decision Date	09/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review