TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
FDA 510(k) clearance K062937 · decided 2007-01-08
Clearance details
- K-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
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-28
- Decision date
- 2007-01-08
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Prob recall (Z-1755-2010) | Baylis Medical Corp * | 2010-06-03 |