The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starband, Starlight.
| Device ID | K141842 |
| 510k Number | K141842 |
| Device Name: | STARBAND, STARLIGHT |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOMERICA PRODUCTS, INC. 6333 N Orange Blossom Trl Orlando, FL 32810 |
| Contact | David C Kerr |
| Correspondent | David C Kerr 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 | 2014-07-08 |
| Decision Date | 2014-10-06 |
| Summary: | summary |