The following data is part of a premarket notification filed by D.s.p Industrial Eireli with the FDA for Dsp Implant System.
Device ID | K192839 |
510k Number | K192839 |
Device Name: | DSP Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | D.S.P Industrial Eireli Rua Marechal Floriano Peixoto 303 - Ouro Verde II Campo Largo, BR 83606-290 |
Contact | Celio Gilson Netzel |
Correspondent | Graziela Brum PR Servicos Regulatorios Administrarivos Ltda Rua Alice Alem Saadi, 855/2404 Ribeirao Preto, BR 14096-770 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-26 |
Decision Date | 2021-02-11 |