FDA 510(k) Application Details - K133316

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K133316
Device Name	Catheter, Conduction, Anesthetic
Applicant	EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK JOHNSTOWN, NY 12095 US Other 510(k) Applications for this Company
Contact	PRESTON H 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	10/28/2013
Decision Date	05/28/2014
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