Device Classification Name |
Orthosis, Cranial, Laser Scan
|
510(k) Number |
K133250 |
Device Name |
STARLIGHT |
Applicant |
ORTHOMERICA PRODUCTS, INC. |
6333 North Orange Blossom Trail |
Orlando,
FL
32810
|
|
Applicant Contact |
DAVID L HOOPER |
Correspondent |
ORTHOMERICA PRODUCTS, INC. |
6333 North Orange Blossom Trail |
Orlando,
FL
32810
|
|
Correspondent Contact |
DAVID L HOOPER |
Regulation Number | 882.5970
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/2013 |
Decision Date | 01/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|