Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K111247 |
Device Name |
CRANIAL REMOLDING ORTHOSIS |
Applicant |
ORTHOTIC CARE SERVICES, LLP |
360 SHERMAN STREET, SUITE 299 |
ST.PAUL,
MN
55102
|
|
Applicant Contact |
SCOTT HINSHON |
Correspondent |
ORTHOTIC CARE SERVICES, LLP |
360 SHERMAN STREET, SUITE 299 |
ST.PAUL,
MN
55102
|
|
Correspondent Contact |
SCOTT HINSHON |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 05/03/2011 |
Decision Date | 08/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|