The following data is part of a premarket notification filed by Neos Surgery S.l. with the FDA for Cranial Cover.
| Device ID | K160739 |
| 510k Number | K160739 |
| Device Name: | Cranial COVER |
| Classification | Cover, Burr Hole |
| Applicant | Neos Surgery S.L. Parc Tecnologic Del Valles, C/Ceramistes, 2 Cerdanyola Del Valles, ES 08290 |
| Contact | Eduard Garcia |
| Correspondent | Marcos Velez-duran M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-17 |
| Decision Date | 2016-06-12 |
| Summary: | summary |