The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Dental Mercury.
Device ID | K093587 |
510k Number | K093587 |
Device Name: | DENTAL MERCURY |
Classification | Mercury |
Applicant | DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
Contact | Pamela Papineau |
Correspondent | Pamela Papineau DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
Product Code | ELY |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-19 |
Decision Date | 2010-01-21 |
Summary: | summary |