The following data is part of a premarket notification filed by Aleaciones Dentales Zeyco, S.a. De C.v. with the FDA for Mercury Dental.
Device ID | K973548 |
510k Number | K973548 |
Device Name: | MERCURY DENTAL |
Classification | Mercury |
Applicant | ALEACIONES DENTALES ZEYCO, S.A. DE C.V. CALZ. LAZARO CARDENAS #2838 COL. JARDINES DEL BOSQUE Guadalajara, MX 44520 |
Contact | Jorge Zepeda Galvez |
Correspondent | Jorge Zepeda Galvez ALEACIONES DENTALES ZEYCO, S.A. DE C.V. CALZ. LAZARO CARDENAS #2838 COL. JARDINES DEL BOSQUE Guadalajara, MX 44520 |
Product Code | ELY |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-18 |
Decision Date | 1998-03-23 |