FDA 510(k) Application Details - K970716

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K970716
Device Name	Catheter, Retention Type, Balloon
Applicant	OPTICON MEDICAL, INC. 14505 21ST AVENUE NORTH SUITE #216 MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	GREG SACHS Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/1997
Decision Date	05/16/1997
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