FDA 510(k) Application Details - K191997

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K191997
Device Name	Plate, Bone
Applicant	FAICO Medical LLC 9689 Parkview Ave. Boca Raton, FL 33428 US Other 510(k) Applications for this Company
Contact	Heman Dario Fernandez Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2019
Decision Date	04/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review