The following data is part of a premarket notification filed by Gme (german Medical Engineering) Gmbh with the FDA for Linscan 808, Linscan 980.
| Device ID | K141063 |
| 510k Number | K141063 |
| Device Name: | LINSCAN 808, LINSCAN 980 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GME (GERMAN MEDICAL ENGINEERING) GMBH PO BOX 106 Willow Creek, MT 59760 |
| Contact | Mike Johnson, M.d. |
| Correspondent | Mike Johnson, M.d. GME (GERMAN MEDICAL ENGINEERING) GMBH PO BOX 106 Willow Creek, MT 59760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B12510420 | K141063 | 000 |