The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Cranioplug.
| Device ID | K140309 |
| 510k Number | K140309 |
| Device Name: | CRANIOPLUG |
| Classification | Cover, Burr Hole |
| Applicant | OSSDSIGN AB 808 WILLIAMSON ST. SUITE 402 Madison, WI 53703 |
| Contact | David Weissburg |
| Correspondent | David Weissburg OSSDSIGN AB 808 WILLIAMSON ST. SUITE 402 Madison, WI 53703 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-07 |
| Decision Date | 2014-10-03 |
| Summary: | summary |