FDA 510(k) Application Details - K143095

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K143095
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	Halyard Health, Inc. 1400 Holcomb Bridge Road Roswell, GA 30076 US Other 510(k) Applications for this Company
Contact	Lindsey Hedlund Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	BXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2014
Decision Date	03/24/2015
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