FDA 510(k) Application Details - K080508

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K080508
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE CHASKA, MN 55318 US Other 510(k) Applications for this Company
Contact	KAREN MORTENSEN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2008
Decision Date	03/21/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review