Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K103362 |
Device Name |
AOI CRANIAL HELMET |
Applicant |
ADVANCED ORTHOPRO INC. |
1820 N. ILLINOIS ST. |
INDIANAPOLIS,
IN
46202
|
|
Applicant Contact |
MOHAMAD MANSOORI |
Correspondent |
ADVANCED ORTHOPRO INC. |
1820 N. ILLINOIS ST. |
INDIANAPOLIS,
IN
46202
|
|
Correspondent Contact |
MOHAMAD MANSOORI |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 11/17/2010 |
Decision Date | 04/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|