The following data is part of a premarket notification filed by Schoelly Fiberoptic, Gmbh with the FDA for Flexiscope Optomodul.
| Device ID | K984641 |
| 510k Number | K984641 |
| Device Name: | FLEXISCOPE OPTOMODUL |
| Classification | Unit, Operative Dental |
| Applicant | SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. Newton, MA 02248 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. Newton, MA 02248 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-31 |
| Decision Date | 1999-03-29 |