The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for S.l.t. Laser Delivery Handles W/surgical Rods.
| Device ID | K844643 |
| 510k Number | K844643 |
| Device Name: | S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills, KY 41017 |
| Contact | Richard L Studer |
| Correspondent | Richard L Studer SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills, KY 41017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-28 |
| Decision Date | 1985-05-10 |