FDA 510(k) Application Details - K202566

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K202566
Device Name	Catheter, Straight
Applicant	Big Blue Biotech, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090 US Other 510(k) Applications for this Company
Contact	Russ Olsen 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	09/04/2020
Decision Date	09/30/2020
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	Y
Expedited Review