The following data is part of a premarket notification filed by Est. Anthogyr with the FDA for Fibiocore.
Device ID | K020431 |
510k Number | K020431 |
Device Name: | FIBIOCORE |
Classification | Post, Root Canal |
Applicant | EST. ANTHOGYR 164 RUE DES TROIS LACS Sallanches, FR 74700 |
Contact | Claude Anthoine |
Correspondent | Claude Anthoine EST. ANTHOGYR 164 RUE DES TROIS LACS Sallanches, FR 74700 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-08 |
Decision Date | 2002-07-03 |
Summary: | summary |