The following data is part of a premarket notification filed by Cranial Technologies, Inc. with the FDA for Doc Band-postop.
| Device ID | K042385 |
| 510k Number | K042385 |
| Device Name: | DOC BAND-POSTOP |
| Classification | Orthosis, Cranial |
| Applicant | CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR. Tempe, AZ 85284 |
| Contact | Timothy R Littlefield |
| Correspondent | Timothy R Littlefield CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR. Tempe, AZ 85284 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-01 |
| Decision Date | 2004-12-17 |
| Summary: | summary |