Device Classification Name |
orthosis, cranial
|
510(k) Number |
K013452 |
Device Name |
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS |
Applicant |
DANMAR PRODUCTS, INC. |
221 JACKSON INDUSTRIAL DR. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
KAREN A LINDNER |
Correspondent |
DANMAR PRODUCTS, INC. |
221 JACKSON INDUSTRIAL DR. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
KAREN A LINDNER |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 10/18/2001 |
Decision Date | 10/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|