FDA 510(k) Application Details - K974454

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K974454
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	TUCSON MEDICAL CORP. 3941 EAST 29TH ST., SUITE 601 TUCSON, AZ 85711 US Other 510(k) Applications for this Company
Contact	JIM PATKO 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	11/25/1997
Decision Date	12/18/1997
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