Device Classification Name |
orthosis, cranial, laser scan
|
510(k) Number |
K081787 |
Device Name |
CAMLAB CRANIAL ORTHOSIS HELMET |
Applicant |
BIOSCULPTOR CORPORATION |
2480 WEST 82ND STREET #8 |
HIALEAH,
FL
33016
|
|
Applicant Contact |
MARK MAZLOFF |
Correspondent |
BIOSCULPTOR CORPORATION |
2480 WEST 82ND STREET #8 |
HIALEAH,
FL
33016
|
|
Correspondent Contact |
MARK MAZLOFF |
Regulation Number | 882.5970
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/24/2008 |
Decision Date | 01/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|