The following data is part of a premarket notification filed by Dornier Surgical Products, Inc. with the FDA for Dornier Lasertrode Fiber.
| Device ID | K991183 |
| 510k Number | K991183 |
| Device Name: | DORNIER LASERTRODE FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER SURGICAL PRODUCTS, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Carol Wernecke |
| Correspondent | Carol Wernecke DORNIER SURGICAL PRODUCTS, 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 | 1999-04-08 |
| Decision Date | 1999-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049958003981 | K991183 | 000 |
| 04049958000072 | K991183 | 000 |
| 04049958000058 | K991183 | 000 |
| 04049958000614 | K991183 | 000 |
| 04049958000621 | K991183 | 000 |
| 04049958000096 | K991183 | 000 |
| 04049958001741 | K991183 | 000 |
| 04049958001130 | K991183 | 000 |
| 04049958001444 | K991183 | 000 |
| 04049958002113 | K991183 | 000 |
| 04049958002137 | K991183 | 000 |
| 04049958002151 | K991183 | 000 |
| 04049958003967 | K991183 | 000 |
| 04049958000065 | K991183 | 000 |