FDA 510(k) Application Details - K242917

Device Classification Name	More FDA Info for this Device
510(K) Number	K242917
Device Name	Enteral Drainage System, Enteral Medicine straw
Applicant	HMC Premedical S.p.a. Via Bosco, 1/3 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Danilo Bosetti 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	09/24/2024
Decision Date	06/18/2025
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