FDA 510(k) Application Details - K160471

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K160471
Device Name	Gown, Isolation, Surgical
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	PAULINE MARALIT Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2016
Decision Date	01/31/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review