The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Quick Disc.
| Device ID | K062857 |
| 510k Number | K062857 |
| Device Name: | KLS MARTIN QUICK DISC |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| 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 | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-11-22 |
| Summary: | summary |