The following data is part of a premarket notification filed by Bego Bremer Goldschlaegerei Wilh. Herbst Gmbh & Co with the FDA for Begopal+.
Device ID | K123929 |
510k Number | K123929 |
Device Name: | BEGOPAL+ |
Classification | Alloy, Metal, Base |
Applicant | BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO WILHELM-HERBST-STRASSE 1 Bremen, DE 28359 |
Contact | Heike Gustke |
Correspondent | Heike Gustke BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO WILHELM-HERBST-STRASSE 1 Bremen, DE 28359 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-20 |
Decision Date | 2013-03-14 |
Summary: | summary |