FDA 510(k) Application Details - K161232

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K161232
Device Name	Catheter, Conduction, Anesthetic
Applicant	HALYARD HEALTH 5405 WINDWARD PARKWAY ALPHARETTA, GA 30004 US Other 510(k) Applications for this Company
Contact	GWENDOLYN GEORGE 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	05/02/2016
Decision Date	09/30/2016
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