The following data is part of a premarket notification filed by Orthomerica Products, Inc with the FDA for Starband, Starlight, St. Louis Band.
| Device ID | K180109 |
| 510k Number | K180109 |
| Device Name: | STARband, STARlight, St. Louis Band |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | Orthomerica Products, Inc 6333 North Orange Blossom Trail Orlando, FL 32810 |
| Contact | David C. Kerr |
| Correspondent | J. Tyler Schulte Orthomerica Products, Inc 6333 North Orange Blossom Trail Orlando, FL 32810 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-03-01 |
| Summary: | summary |