FDA 510(k) Application Details - K964955

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K964955
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	PAM L SCHAUB 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	12/11/1996
Decision Date	02/14/1997
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