FDA 510(k) Application Details - K182609

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K182609
Device Name	Plate, Bone
Applicant	Delphos Implants - Ind.Com. Importacao e Exportacao de Implants Medicos S.A Estrada Manuel Correia Lopes, Parque Empresarial Progresso, Armazem. No5 Cascais 2785-126 PT Other 510(k) Applications for this Company
Contact	Vitor Monsanto 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	09/21/2018
Decision Date	03/29/2019
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