FDA 510(k) Application Details - K181811

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K181811
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Cori Ragan Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2018
Decision Date	09/07/2018
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