The following data is part of a premarket notification filed by Cranial Solutions with the FDA for Cranial Solution Orthosis.
| Device ID | K063133 |
| 510k Number | K063133 |
| Device Name: | CRANIAL SOLUTION ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | CRANIAL SOLUTIONS 602 LINCOLN AVE. Pompton Lakes, NJ 07442 |
| Contact | Kirk A Lucyk |
| Correspondent | Kirk A Lucyk CRANIAL SOLUTIONS 602 LINCOLN AVE. Pompton Lakes, NJ 07442 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-13 |
| Decision Date | 2007-07-02 |
| Summary: | summary |