The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Neuromed Octrode Model Mnr-88a-b-c Neurostim Rec.
| Device ID | K930536 |
| 510k Number | K930536 |
| Device Name: | NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale, FL 33314 |
| Contact | Dale Sappenfield |
| Correspondent | Dale Sappenfield 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 | 1993-01-27 |
| Decision Date | 1994-12-15 |