FDA 510(k) Application Details - K152948

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K152948
Device Name	Anti Fog Solution And Accessories, Endoscopy
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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2015
Decision Date	02/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review