The following data is part of a premarket notification filed by Danmar Products, Inc. with the FDA for Danmar Products Cranial Adjustive Prosthesis.
| Device ID | K013452 |
| 510k Number | K013452 |
| Device Name: | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS |
| Classification | Orthosis, Cranial |
| Applicant | DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor, MI 48103 |
| Contact | Karen A Lindner |
| Correspondent | Karen A Lindner DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor, MI 48103 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2003-10-31 |
| Summary: | summary |