The following data is part of a premarket notification filed by Symbion Logistics, Llc with the FDA for Hanger Cranial Band 3d.
| Device ID | K203134 |
| 510k Number | K203134 |
| Device Name: | Hanger Cranial Band 3D |
| Classification | Orthosis, Cranial |
| Applicant | Symbion Logistics, LLC 1119 W Geneva Dr Tempe, AZ 85281 |
| Contact | Roselle Abad |
| Correspondent | Roselle Abad Symbion Logistics, LLC 1119 W Geneva Dr Tempe, AZ 85281 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-19 |
| Decision Date | 2022-07-01 |