FDA 510(k) Application Details - K162930

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K162930
Device Name	Gown, Surgical
Applicant	Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 US Other 510(k) Applications for this Company
Contact	David M. Lee Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2016
Decision Date	04/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review