DEN980001 is an FDA 510(k) submission for the DYNAMIC ORTHOTIC CRANIOPLASTY BAND. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Cranial Technologies, Inc. (Phoenix, US). The FDA issued a Not Cleared (DENG) decision on May 29, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | DEN980001 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 31, 1998 |
| Decision Date | May 29, 1998 |
| Days to Decision | 59 days |
| Submission Type | Post-NSE |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | MVA - Orthosis, Cranial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |