FDA 510(k) Application Details - K200624

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K200624
Device Name	Catheter, Conduction, Anesthetic
Applicant	Epimed International Inc. 13958 Diplomat Drive Farmers Branch, TX 75234 US Other 510(k) Applications for this Company
Contact	Preston Frasier 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	03/10/2020
Decision Date	04/27/2020
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	Y
Expedited Review