The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Sirius 10, 10l, 40, 40l.
| Device ID | K961275 |
| 510k Number | K961275 |
| Device Name: | SIRIUS 10, 10L, 40, 40L |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Contact | Jim Badoz |
| Correspondent | Jim Badoz MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1997-01-17 |