The following data is part of a premarket notification filed by Bego Bremer Goldschlaegerei Wilh. Herbst Gmbh & Co with the FDA for Begopal 300.
Device ID | K983081 |
510k Number | K983081 |
Device Name: | BEGOPAL 300 |
Classification | Alloy, Other Noble Metal |
Applicant | BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO WILHELM-HERBST-STRASSE 1 Bremen, DE 28359 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-02 |
Decision Date | 1998-10-28 |