Device Classification Name |
orthosis, cranial
|
510(k) Number |
K021221 |
Device Name |
O&P CRANICAL MOLDING HELMET |
Applicant |
ORTHOTIC & PROSTHETIC LAB, INC. |
748 MARSHALL AVE. |
WEBSTER GROVES,
MO
63119
|
|
Applicant Contact |
THOMAS MALONE |
Correspondent |
ORTHOTIC & PROSTHETIC LAB, INC. |
748 MARSHALL AVE. |
WEBSTER GROVES,
MO
63119
|
|
Correspondent Contact |
THOMAS MALONE |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 04/17/2002 |
Decision Date | 07/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|