The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Trial Cable Retention Clip.
Device ID | K050633 |
510k Number | K050633 |
Device Name: | TRIAL CABLE RETENTION CLIP |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
Contact | Rashmi Moza |
Correspondent | Rashmi Moza 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 | 2005-03-11 |
Decision Date | 2005-04-21 |