The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Multistim(4-channel), Multistim-octrode(8 Channel).
| Device ID | K862915 |
| 510k Number | K862915 |
| Device Name: | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) |
| 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 | 1986-08-01 |
| Decision Date | 1986-10-06 |