FDA 510(k) Application Details - K181643

Device Classification Name	Collector, Ostomy   More FDA Info for this Device
510(K) Number	K181643
Device Name	Collector, Ostomy
Applicant	11 Health Technologies Limited The Kinetic Business Centre, Theobald Street Borehamwood WD6 4PJ GB Other 510(k) Applications for this Company
Contact	Michael Seres Other 510(k) Applications for this Contact
Regulation Number	876.5900   More FDA Info for this Regulation Number
Classification Product Code	EXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2018
Decision Date	11/16/2018
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