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 |