The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Ossdsign Cranioplug.
| Device ID | K181539 |
| 510k Number | K181539 |
| Device Name: | OSSDSIGN Cranioplug |
| Classification | Cover, Burr Hole |
| Applicant | OssDsign AB Virdings Alle 2 Uppsala, SE Se 754 50 |
| Contact | Ulrik Birgersson |
| Correspondent | David Weissburg Weissburg Associates 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 | 2018-06-11 |
| Decision Date | 2018-10-12 |
| Summary: | summary |