FDA 510(k) Application Details - K212514

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K212514
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Berpu Medical Technology Co., Ltd. NO.14 Xingji Road,Yongxing Street, Longwan District Wenzhou 325000 CN Other 510(k) Applications for this Company
Contact	Buxin Yu 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	08/10/2021
Decision Date	04/29/2022
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