The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Cinch Anchor, Model 1194.
| Device ID | K081208 |
| 510k Number | K081208 |
| Device Name: | CINCH ANCHOR, MODEL 1194 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-29 |
| Decision Date | 2008-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734400685 | K081208 | 000 |