FDA 510(k) Application Details - K210216

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K210216
Device Name	Syringe, Antistick
Applicant	Shantou Wealy Medical Instrument CO.,Ltd North Jinhuan Road Shantou 515064 CN Other 510(k) Applications for this Company
Contact	Yuhe Yang 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	01/27/2021
Decision Date	03/04/2022
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