FDA 510(k) Application Details - K210991

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K210991
Device Name	Syringe, Piston
Applicant	Guangdong Antmed Co., Ltd. Rm 201, Bld 3, Hualian Ave, Songshanhu District Dongguan 523800 CN Other 510(k) Applications for this Company
Contact	Zhiying Zhong Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2021
Decision Date	08/26/2021
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