The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Sirius 180, 180l, 230, 230l.
| Device ID | K961235 |
| 510k Number | K961235 |
| Device Name: | SIRIUS 180, 180L, 230, 230L |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Contact | Jm Badoz |
| Correspondent | Jm 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 | 1996-03-29 |
| Decision Date | 1997-01-08 |