The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Model 5050 Surgilaser For Gastro-intestinal Use.
| Device ID | K871934 |
| 510k Number | K871934 |
| Device Name: | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE |
| Classification | Laser For Gastro-urology Use |
| Applicant | LASERMATIC, INC. P.O. BOX 7848 Dallas, TX 75209 |
| Contact | Donald F Hults |
| Correspondent | Donald F Hults LASERMATIC, INC. P.O. BOX 7848 Dallas, TX 75209 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-19 |
| Decision Date | 1988-03-25 |