FDA 510(k) Application Details - K220614

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K220614
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Chirana T. Injecta Nßm. Dr. Schweitzera 194 Starß Turß 916 01 SK Other 510(k) Applications for this Company
Contact	Zdenka Klbeckova 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	03/03/2022
Decision Date	06/15/2022
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