FDA 510(k) Application Details - K063587

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K063587
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	XODUS MEDICAL, INC. 702 PROMINENCE DR. NEW KENSINGTON, PA 15068 US Other 510(k) Applications for this Company
Contact	BRENDA NIEL 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	12/01/2006
Decision Date	01/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review