FDA 510(k) Application Details - K231299

Device Classification Name	More FDA Info for this Device
510(K) Number	K231299
Device Name	Nutricair enteral ENFit adapter: ENFit male û stepped/Christmas tree connector
Applicant	Cair LGL 1, AllΘe des Chevreuls Lissieu 69380 FR Other 510(k) Applications for this Company
Contact	Irving L Wiesen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2023
Decision Date	01/22/2024
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