The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Leksell Gammaplan (lgp).
| Device ID | K914808 |
| 510k Number | K914808 |
| Device Name: | LEKSELL GAMMAPLAN (LGP) |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Contact | Richard S Grome |
| Correspondent | Richard S Grome ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-25 |
| Decision Date | 1992-01-23 |