The following data is part of a premarket notification filed by Top Corp. with the FDA for Top Neuropole Needles, Models St, X, Rc, Xe And Tl.
| Device ID | K062946 |
| 510k Number | K062946 |
| Device Name: | TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | TOP CORP. 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria TOP CORP. 5536 TROWBRIDGE DRIVE 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 | 2006-09-28 |
| Decision Date | 2007-02-15 |
| Summary: | summary |