The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Molina Orbital Malar Distractor.
| Device ID | K003883 |
| 510k Number | K003883 |
| Device Name: | MOLINA ORBITAL MALAR DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Mike Teague |
| Correspondent | Mike Teague KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-15 |
| Decision Date | 2001-01-23 |