The following data is part of a premarket notification filed by Anthogyr Sas with the FDA for Axiom 2.8.
Device ID | K141450 |
510k Number | K141450 |
Device Name: | AXIOM 2.8 |
Classification | Implant, Endosseous, Root-form |
Applicant | ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Contact | Therese Candau |
Correspondent | Therese Candau ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-02 |
Decision Date | 2014-09-17 |
Summary: | summary |