The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Transdiscal System, Models Tdp-17-150-6, Tdi-17-150, Tda-ppu-1, Tda-tbk-1, Tdx-y-tsw-tdp, Tdx-pmg-ppu.
| Device ID | K062937 |
| 510k Number | K062937 |
| Device Name: | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| 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 | 2007-01-08 |
| Summary: | summary |