Device Classification Name |
Orthosis, Cranial, Laser Scan
|
510(k) Number |
K063098 |
Device Name |
STATIC CRANIOPLASTY ORTHOSIS |
Applicant |
BOSTON BRACE INTL., INC. |
20 LEDIN DR. |
AVON,
MA
02322
|
|
Applicant Contact |
JAMES WYNNE |
Correspondent |
BOSTON BRACE INTL., INC. |
20 LEDIN DR. |
AVON,
MA
02322
|
|
Correspondent Contact |
JAMES WYNNE |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 10/10/2006 |
Decision Date | 04/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|