K203134 is an FDA 510(k) clearance for the Hanger Cranial Band 3D. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Symbion Logistics, LLC (Tempe, US). The FDA issued a Cleared decision on July 1, 2022, 620 days after receiving the submission on October 19, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | K203134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2020 |
| Decision Date | July 01, 2022 |
| Days to Decision | 620 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVA - Orthosis, Cranial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |