The following data is part of a premarket notification filed by Danmar Products, Inc. with the FDA for Danmar Products Michigan Cranial Helmet.
| Device ID | K003630 |
| 510k Number | K003630 |
| Device Name: | DANMAR PRODUCTS MICHIGAN CRANIAL HELMET |
| 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 | 2000-11-24 |
| Decision Date | 2001-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862948000302 | K003630 | 000 |