The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Medilas D 30 Laser, Medilas D 1064.
| Device ID | K080959 |
| 510k Number | K080959 |
| Device Name: | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Theron Gober |
| Correspondent | Theron Gober DORNIER MEDTECH AMERICA, INC. 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 | 2008-04-03 |
| Decision Date | 2008-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049958002090 | K080959 | 000 |