K972047 is an FDA 510(k) clearance for the KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE. This device is classified as a External Mandibular Fixator And/or Distractor (Class II - Special Controls, product code MQN).
Submitted by KLS-Martin L.P. (Tarpon Springs, US). The FDA issued a Cleared decision on June 24, 1997, 22 days after receiving the submission on June 2, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K972047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1997 |
| Decision Date | June 24, 1997 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MQN — External Mandibular Fixator And/or Distractor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |