The following data is part of a premarket notification filed by Micro-mega with the FDA for Hero 642.
| Device ID | K970649 |
| 510k Number | K970649 |
| Device Name: | HERO 642 |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | MICRO-MEGA 5-12 RUE DU TUNNEL 25006 BESANCON France, FR |
| Contact | Jm Badoz |
| Correspondent | Jm Badoz MICRO-MEGA 5-12 RUE DU TUNNEL 25006 BESANCON France, FR |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-05-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HERO 642 76688460 3629160 Dead/Cancelled |
Micro-Mega International Manufactures 2008-04-08 |
![]() HERO 642 75264092 2182030 Dead/Cancelled |
MICRO MEGA INTERNATIONAL MANUFACTURES, S.A. 1997-03-26 |