The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas 4060n Fibertom(r) Surgical Laser.
| Device ID | K904155 |
| 510k Number | K904155 |
| Device Name: | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 824 LIVINGSTON COURT Marietta, GA 30067 |
| Contact | Robert E Yocher |
| Correspondent | Robert E Yocher DORNIER MEDTECH AMERICA, INC. 824 LIVINGSTON COURT Marietta, GA 30067 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-07 |
| Decision Date | 1990-11-21 |