FDA 510(k) Application Details - K960866

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K960866
Device Name	Accessories, Catheter, G-U
Applicant	LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. CHASKA, MN 55318 US Other 510(k) Applications for this Company
Contact	KIM E AVES Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1996
Decision Date	04/05/1996
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