The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Ans 90 Cm And 110 Cm (3100 And 3200 Series) Lead Kit.
| Device ID | K053250 |
| 510k Number | K053250 |
| Device Name: | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Danielle Alarcon |
| Correspondent | Danielle Alarcon ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2005-12-15 |