The following data is part of a premarket notification filed by Danmar Products, Inc. with the FDA for Michigan Cranial Reshaping Orthosis.
| Device ID | K090341 |
| 510k Number | K090341 |
| Device Name: | MICHIGAN CRANIAL RESHAPING ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | DANMAR PRODUCTS, INC. 537 FORT DEARBORN STREET Dearborn, MI 48124 |
| Contact | Kay Fuller, Rac |
| Correspondent | Kay Fuller, Rac DANMAR PRODUCTS, INC. 537 FORT DEARBORN STREET Dearborn, MI 48124 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2010-01-06 |
| Summary: | summary |