K920567 is an FDA 510(k) clearance for the MODELS 3987 AND 3988 RESUME LEAD FOR PNS. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 20, 1992, 103 days after receiving the submission on February 7, 1992.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K920567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1992 |
| Decision Date | May 20, 1992 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZF — Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5870 |