Device Classification Name |
orthosis, cranial
|
510(k) Number |
K041215 |
Device Name |
CRANIAL HELMET |
Applicant |
OTTO BOCK HEALTH CARE, LP |
2 CARLSON PWY. STE. 100 |
MINNEAPOLIS,
MN
55447 -4467
|
|
Applicant Contact |
SHELLEY STOCKMAN |
Correspondent |
OTTO BOCK HEALTH CARE, LP |
2 CARLSON PWY. STE. 100 |
MINNEAPOLIS,
MN
55447 -4467
|
|
Correspondent Contact |
SHELLEY STOCKMAN |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 09/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|