FDA 510(k) Application Details - K212407

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K212407
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Naser Dib Gabinet Lekarksi Nasmed Ul Jana Nowaka Jezioranskiego 7/184 Warszawa 03-984 PL Other 510(k) Applications for this Company
Contact	Naser Dib Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2021
Decision Date	07/26/2022
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