The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Visio-gem.
Device ID | K833757 |
510k Number | K833757 |
Device Name: | VISIO-GEM |
Classification | Material, Tooth Shade, Resin |
Applicant | ESPE GMBH (US) CA |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-26 |
Decision Date | 1984-02-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISIO-GEM 73442414 1313056 Dead/Cancelled |
Espe Fabrik Pharmazeutischer Praparate GmbH 1983-09-06 |