FDA 510(k) Application Details - K211484

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K211484
Device Name	Syringe, Antistick
Applicant	Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road, Zibo 255086 CN Other 510(k) Applications for this Company
Contact	Xiaolei Tian Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2021
Decision Date	03/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review