The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for 8-channel Multiprog Implant Spinal Cord Stimulator.
| Device ID | K860158 |
| 510k Number | K860158 |
| Device Name: | 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. P.O. BOX 290010 Davies, FL 33329 |
| Contact | Frank Liska |
| Correspondent | Frank Liska NEUROMED, INC. P.O. BOX 290010 Davies, FL 33329 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-16 |
| Decision Date | 1986-03-07 |