FDA 510(k) Application Details - K160858

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K160858
Device Name	Catheter, Straight
Applicant	COMPACTCATH INC. 887 FEDERATION WAY Palo Alto, CA 94303 US Other 510(k) Applications for this Company
Contact	Naama Stauber Breckler Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2016
Decision Date	04/26/2016
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