The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Trial Cable, 3009.
Device ID | K070847 |
510k Number | K070847 |
Device Name: | TRIAL CABLE, 3009 |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
Contact | Penny Houston |
Correspondent | Penny Houston 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 | 2007-03-28 |
Decision Date | 2007-04-11 |