The following data is part of a premarket notification filed by St. Jude Medical Neuromodulation with the FDA for Octrodex(tm), Quattrodex(tm), Introdex(tm), Epidural Needle, Stylets.
| Device ID | K112214 |
| 510k Number | K112214 |
| Device Name: | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ST. JUDE MEDICAL NEUROMODULATION 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Penny Houston |
| Correspondent | Penny Houston ST. JUDE MEDICAL NEUROMODULATION 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2011-11-17 |