The following data is part of a premarket notification filed by Dornier Surgical Products, Inc. with the FDA for Dornier Medilas H.
| Device ID | K001243 |
| 510k Number | K001243 |
| Device Name: | DORNIER MEDILAS H |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER SURGICAL PRODUCTS, INC. 8623 N. LAGOON DR. SUITE C3 Panama Cyt Bch, FL |
| Contact | Joe D Brown |
| Correspondent | Joe D Brown DORNIER SURGICAL PRODUCTS, INC. 8623 N. LAGOON DR. SUITE C3 Panama Cyt Bch, FL |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-05-24 |