FDA 510(k) Application Details - K193664

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K193664
Device Name	Catheter, Conduction, Anesthetic
Applicant	HK Surgical 1271 Puerto del Sol San Clemente, CA 92673 US Other 510(k) Applications for this Company
Contact	Gary Mocnik 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	12/31/2019
Decision Date	09/09/2020
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