The following data is part of a De Novo classification by Cranial Technologies, Inc. with the FDA for Dynamic Orthotic Cranioplasty Band; Doc Band.
| DeNovo ID | DEN980001 |
| Device Name: | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND |
| Classification | Orthosis, Cranial |
| Applicant | CRANIAL TECHNOLOGIES, INC. 1331 North 7th St., Suite 170 Phoenix, AZ 85006 |
| Contact | Timothy R Littlefield |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K964992 |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 1998-03-31 |
| Decision Date | 1998-05-29 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B288CRANIALHELMET0 | DEN980001 | 000 |