FDA 510(k) Application Details - K212982

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K212982
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	Global Medikit Limited Khasra No 323 MI, Camp Road, Selaqui, Dehradun 248197 IN Other 510(k) Applications for this Company
Contact	Karun Narang Other 510(k) Applications for this Contact
Regulation Number	868.5150   More FDA Info for this Regulation Number
Classification Product Code	BSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2021
Decision Date	07/29/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review