K925106 is an FDA 510(k) clearance for the IMPLANTABLE PULSE GENERATORS. This device is classified as a Lock, Wire, And Ligature, Intraoral (Class II - Special Controls, product code DYX).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1993, 362 days after receiving the submission on October 9, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4600.
| 510(k) Number | K925106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1992 |
| Decision Date | October 06, 1993 |
| Days to Decision | 362 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYX — Lock, Wire, And Ligature, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4600 |