The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starband And Starlight.
| Device ID | K140353 |
| 510k Number | K140353 |
| Device Name: | STARBAND AND STARLIGHT |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOMERICA PRODUCTS, INC. 6333 N Orange Blossom Trl Orlando, FL 32810 |
| Contact | David L Hooper |
| Correspondent | David L Hooper ORTHOMERICA PRODUCTS, INC. 6333 N Orange Blossom Trl Orlando, FL 32810 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-12 |
| Decision Date | 2014-06-06 |
| Summary: | summary |