The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Series Xe, Series Se, Series Te.
| Device ID | K971350 |
| 510k Number | K971350 |
| Device Name: | SERIES XE, SERIES SE, SERIES TE |
| Classification | Handpiece, Contra- And Right-angle Attachment, 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 | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-06-04 |