The following data is part of a premarket notification filed by Mayo Clinic with the FDA for Kelly-groerss-kall Ct Sterotactic Adaptation Sys.
| Device ID | K852477 |
| 510k Number | K852477 |
| Device Name: | KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Mayo Clinic Rochester, MN 55905 |
| Contact | Kall, M.s. |
| Correspondent | Kall, M.s. Mayo Clinic Rochester, MN 55905 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-11 |
| Decision Date | 1985-07-30 |