FDA 510(k) Application Details - K243361

Device Classification Name	Tube, Feeding   More FDA Info for this Device
510(K) Number	K243361
Device Name	Tube, Feeding
Applicant	Vygon USA 2750 Morris Road Suite A200 Lansdale, PA 19446 US Other 510(k) Applications for this Company
Contact	Chris Steinke Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	FPD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2024
Decision Date	12/19/2024
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