The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Ans Scs Accessory Kit.
| Device ID | K050922 |
| 510k Number | K050922 |
| Device Name: | ANS SCS ACCESSORY 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 | 2005-04-13 |
| Decision Date | 2005-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734400128 | K050922 | 000 |