The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Transdiscal System (transdiscal Probe), Model Tdp-17-150-6.
| Device ID | K031951 |
| 510k Number | K031951 |
| Device Name: | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7 |
| Contact | Kris Shah |
| Correspondent | Kris Shah BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-24 |
| Decision Date | 2003-09-11 |