The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Patient Contoured Mesh-peek (pcm-p).
| Device ID | K072707 |
| 510k Number | K072707 |
| Device Name: | PATIENT CONTOURED MESH-PEEK (PCM-P) |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. 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 | 2007-09-25 |
| Decision Date | 2007-12-19 |
| Summary: | summary |