FDA 510(k) Application Details - K161672

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K161672
Device Name	Catheter, Urethral
Applicant	Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Rebecca S. Roberts 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	06/09/2016
Decision Date	09/29/2016
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