FDA 510(k) Application Details - K210971

Device Classification Name	More FDA Info for this Device
510(K) Number	K210971
Device Name	EnteraLoc Flow
Applicant	Vonco Products 10826 250th Avenue Trevor, WI 53179 US Other 510(k) Applications for this Company
Contact	Christie Marr Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2021
Decision Date	08/18/2021
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