The following data is part of a premarket notification filed by Top Corp. with the FDA for Top Neuropole Needle, Model Sh, Bl, Sc, Tc.
| Device ID | K080771 |
| 510k Number | K080771 |
| Device Name: | TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | TOP CORP. 5536 TROWBRIDGE DR Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria TOP CORP. 5536 TROWBRIDGE DR Dunwoody, GA 30338 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-11-10 |
| Summary: | summary |