FDA 510(k) Application Details - K222452

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K222452
Device Name	Syringe, Antistick
Applicant	Shantou Wealy Medical Instrument CO.,Ltd. North Jinhuan Road (near of Qishan mid-school) Shantou 515064 CN Other 510(k) Applications for this Company
Contact	Yanjun Zhu 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	08/15/2022
Decision Date	11/23/2022
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