The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Introde Int-8.
| Device ID | K930242 |
| 510k Number | K930242 |
| Device Name: | INTRODE INT-8 |
| 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 | 1993-01-19 |
| Decision Date | 1994-02-02 |