The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Sonicweld Rx Endobrow Fixation.
| Device ID | K061507 |
| 510k Number | K061507 |
| Device Name: | SONICWELD RX ENDOBROW FIXATION |
| Classification | Plate, Bone |
| Applicant | KLS-MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY 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 | 2006-06-01 |
| Decision Date | 2006-09-21 |
| Summary: | summary |