The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Tender Fiber.
Device ID | K063170 |
510k Number | K063170 |
Device Name: | TENDER FIBER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
Contact | Eugenio Miceli |
Correspondent | Eugenio Miceli MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-18 |
Decision Date | 2007-01-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TENDER FIBER 79053029 3567952 Live/Registered |
MICERIUM SPA 2008-02-27 |