K994154 is an FDA 510(k) clearance for the MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on February 15, 2000, 68 days after receiving the submission on December 9, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K994154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1999 |
| Decision Date | February 15, 2000 |
| Days to Decision | 68 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 |