The following data is part of a premarket notification filed by Dornier with the FDA for Dornier Medilas R.
| Device ID | K984349 |
| 510k Number | K984349 |
| Device Name: | DORNIER MEDILAS R |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Carol Wernecke |
| Correspondent | Carol Wernecke DORNIER 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-02-04 |
| Summary: | summary |