FDA 510(k) Application Details - K240059

Device Classification Name	More FDA Info for this Device
510(K) Number	K240059
Device Name	FAgamin«
Applicant	Tedequim SRL Bv. Los Polacos 6136. C≤rdoba X5147GGP AR Other 510(k) Applications for this Company
Contact	Leonor Pasteris Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2024
Decision Date	05/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review