FDA 510(k) Application Details - K231300

Device Classification Name	More FDA Info for this Device
510(K) Number	K231300
Device Name	Nutricair Enteral Syringe with ENFit
Applicant	Cair LG 1, AllΘe des Chevreuls Lissieu 69380 FR Other 510(k) Applications for this Company
Contact	Irving L. Wiesen, Esq. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2023
Decision Date	10/06/2023
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