FDA 510(k) Application Details - K191633

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K191633
Device Name	Catheter, Urethral
Applicant	Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 US Other 510(k) Applications for this Company
Contact	Michelle Schiltz-Taing Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2019
Decision Date	07/19/2019
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