The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Modification To Cranioplastic, Model 43-1280.
| Device ID | K071791 |
| 510k Number | K071791 |
| Device Name: | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Rachel Creane |
| Correspondent | Rachel Creane Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-07-30 |
| Summary: | summary |