FDA 510(k) Application Details - K213258

Device Classification Name	More FDA Info for this Device
510(K) Number	K213258
Device Name	Nasogastric Feeding Tubes - ENFit Port - PVC
Applicant	Cair Lgl Parc Tertiaire De Bois Dieu, 1 Allee Des Chevreuils 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	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	06/09/2022
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