The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Unistim Unt-1.
| Device ID | K852326 |
| 510k Number | K852326 |
| Device Name: | UNISTIM UNT-1 |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale, FL 33314 |
| Contact | William F Jackson |
| Correspondent | William F Jackson 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 | 1985-05-30 |
| Decision Date | 1985-11-14 |