The following data is part of a premarket notification filed by Immedica, Inc. with the FDA for Concert Cranioplast.
| Device ID | K023575 |
| 510k Number | K023575 |
| Device Name: | CONCERT CRANIOPLAST |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | IMMEDICA, INC. 719 A STREET, NE Washington, DC 20002 |
| Contact | Russell Pagano |
| Correspondent | Russell Pagano IMMEDICA, INC. 719 A STREET, NE Washington, DC 20002 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-24 |
| Decision Date | 2003-01-22 |
| Summary: | summary |