FDA 510(k) Application Details - K173541

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K173541
Device Name	Catheter, Conduction, Anesthetic
Applicant	Imedicom Co., Ltd. #612, 172, LS-ro Gunpo-si 435824 KR Other 510(k) Applications for this Company
Contact	Priscilla Chung Other 510(k) Applications for this Contact
Regulation Number	868.5120   More FDA Info for this Regulation Number
Classification Product Code	BSO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2017
Decision Date	08/24/2018
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