The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Model Md-45 Co2 Laser For Ob-gyn & Urological Use.
| Device ID | K881581 |
| 510k Number | K881581 |
| Device Name: | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE |
| 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 | 1988-04-11 |
| Decision Date | 1988-06-03 |