FDA 510(k) Application Details - K954147

Device Classification Name	Catheter, Malecot   More FDA Info for this Device
510(K) Number	K954147
Device Name	Catheter, Malecot
Applicant	MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	MICHAEL PLISHKA Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	FEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/1995
Decision Date	03/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review