Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K013719 |
Device Name |
BECKER BAND CRANIAL REMOLDING ORTHOSIS |
Applicant |
BECKER ORTHOPEDIC APPLIANCE CO. |
635 EXECUTIVE DR. |
TROY,
MI
48083
|
|
Applicant Contact |
JAMES H CAMPBELL |
Correspondent |
BECKER ORTHOPEDIC APPLIANCE CO. |
635 EXECUTIVE DR. |
TROY,
MI
48083
|
|
Correspondent Contact |
JAMES H CAMPBELL |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 11/08/2001 |
Decision Date | 02/05/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|