The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Neuromed Octrode Model Mnr-88b/88c Neurostim Syst.
| Device ID | K905596 |
| 510k Number | K905596 |
| Device Name: | NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale, FL 33314 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale, FL 33314 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-13 |
| Decision Date | 1991-03-11 |