FDA 510(k) Application Details - K203668

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K203668
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	MYCO Medical Supplies, Inc. 2015 Production Drive Apex, NC 27539 US Other 510(k) Applications for this Company
Contact	Sanjiv Krumar 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	12/16/2020
Decision Date	09/29/2021
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