The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Track 1.0 & 1.5 Mm Systems-tissue Regeneration By Alveolar Callus Distraction.
| Device ID | K002152 |
| 510k Number | K002152 |
| Device Name: | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-10-10 |