K873675 is an FDA 510(k) clearance for the MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1987, 22 days after receiving the submission on September 14, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K873675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1987 |
| Decision Date | October 06, 1987 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |