Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K013458 |
Device Name |
CRANIAL HELMET |
Applicant |
CHILDREN'S HOSPITAL |
5353 WAYZATA BLVD. |
MINNEAPOLIS,
MN
55416 -1334
|
|
Applicant Contact |
CONNIE FICKLIN |
Correspondent |
CHILDREN'S HOSPITAL |
5353 WAYZATA BLVD. |
MINNEAPOLIS,
MN
55416 -1334
|
|
Correspondent Contact |
CONNIE FICKLIN |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 10/18/2001 |
Decision Date | 10/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|