The following data is part of a premarket notification filed by Bego U.s.a. with the FDA for Begocer G.
Device ID | K983082 |
510k Number | K983082 |
Device Name: | BEGOCER G |
Classification | Alloy, Gold-based Noble Metal |
Applicant | BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket, RI 02860 |
Contact | William Oremus |
Correspondent | William Oremus BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket, RI 02860 |
Product Code | EJT |
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 |