The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Zurich Pediatric Maxillary Distractor, Models 51-550-15 And 51-551-15.
| Device ID | K000580 |
| 510k Number | K000580 |
| Device Name: | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 |
| 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 | 2000-02-22 |
| Decision Date | 2000-07-24 |