Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K020448 |
Device Name |
STATIC CRANIOPLASTY ORTHOSIS |
Applicant |
EASTERN CRANIAL AFFILIATES |
2525 NORTH TENTH ST. # 804 |
ARLINGTON,
VA
22201
|
|
Applicant Contact |
JOSEPH TERPENNING |
Correspondent |
EASTERN CRANIAL AFFILIATES |
2525 NORTH TENTH ST. # 804 |
ARLINGTON,
VA
22201
|
|
Correspondent Contact |
JOSEPH TERPENNING |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 02/11/2002 |
Decision Date | 04/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|