K980927 is an FDA 510(k) clearance for the LACTOSORB PANELS AND FASTENERS. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 5, 1998, 86 days after receiving the submission on March 11, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K980927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1998 |
| Decision Date | June 05, 1998 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |