The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Leksell Stereoactic System.
| Device ID | K811726 |
| 510k Number | K811726 |
| Device Name: | LEKSELL STEREOACTIC SYSTEM |
| Classification | Warmer, Microwave, Infusion Fluid |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHF |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-18 |
| Decision Date | 1981-07-10 |