FDA 510(k) Application Details - K233037

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K233037
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Zhejiang Kindly Medical Device Co., Ltd. 758 Binhai 5th Avenue, Binhai Industrial Park Longwan Wenzhou City 325025 CN Other 510(k) Applications for this Company
Contact	Zhang Qian 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	09/25/2023
Decision Date	12/12/2023
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