The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Duraform Dural Graft Implant.
| Device ID | K152481 |
| 510k Number | K152481 |
| Device Name: | DURAFORM Dural Graft Implant |
| Classification | Dura Substitute |
| Applicant | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Jennifer Siu |
| Correspondent | Jennifer Siu CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2015-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830048941 | K152481 | 000 |
| 10886704079453 | K152481 | 000 |
| 20886704079443 | K152481 | 000 |
| 10886704079439 | K152481 | 000 |
| 20886704079429 | K152481 | 000 |
| 00813954025902 | K152481 | 000 |
| 00813954025896 | K152481 | 000 |
| 00813954025889 | K152481 | 000 |
| 00813954025872 | K152481 | 000 |
| 20886704079467 | K152481 | 000 |
| 10886704079477 | K152481 | 000 |
| 20886704079481 | K152481 | 000 |
| 00382830048927 | K152481 | 000 |
| 00382830048903 | K152481 | 000 |
| 00382830048880 | K152481 | 000 |
| 00382830048934 | K152481 | 000 |
| 00382830048910 | K152481 | 000 |
| 00382830048897 | K152481 | 000 |
| 00382830048873 | K152481 | 000 |
| 10886704079491 | K152481 | 000 |
| 00813954025865 | K152481 | 000 |