The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Md Co2 Surgical Laser System/gen. Surgery And Orth.
| Device ID | K905676 |
| 510k Number | K905676 |
| Device Name: | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Contact | Robert I Rudko |
| Correspondent | Robert I Rudko LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-18 |
| Decision Date | 1991-04-22 |