FDA 510(k) Application Details - K103718

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K103718
Device Name	Lubricant, Patient
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	MATT CLAUSEN Other 510(k) Applications for this Contact
Regulation Number	880.6375   More FDA Info for this Regulation Number
Classification Product Code	KMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2010
Decision Date	05/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review