Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K010273 |
Device Name |
CRANIAL MOLDING ORTHOSIS |
Applicant |
ORTHOTIC SOLUTIONS, INC. |
2802 MERRILEE DR. |
SUITE 100 |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
JOSEPH F TERPENNING |
Correspondent |
ORTHOTIC SOLUTIONS, INC. |
2802 MERRILEE DR. |
SUITE 100 |
FAIRFAX,
VA
22031
|
|
Correspondent Contact |
JOSEPH F TERPENNING |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 01/29/2001 |
Decision Date | 04/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|