The following data is part of a premarket notification filed by Bego U.s.a. with the FDA for Wirobond C.
Device ID | K032136 |
510k Number | K032136 |
Device Name: | WIROBOND C |
Classification | Alloy, Metal, Base |
Applicant | BEGO U.S.A. 24 ALBION RD. SUITE 103 Lincoln, RI 02865 |
Contact | William Oremus |
Correspondent | William Oremus BEGO U.S.A. 24 ALBION RD. SUITE 103 Lincoln, RI 02865 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-11 |
Decision Date | 2003-09-04 |