Device Classification Name |
Cranial Surgical Planning And Instrument Guides
|
510(k) Number |
K182889 |
Device Name |
KLS Martin Individual Patient Solutions (IPS) Planning System |
Applicant |
KLS-Martin L.P. |
11201 Saint Johns Industrial Parkway S |
Jacksonville,
FL
32246
|
|
Applicant Contact |
Jennifer Damato |
Correspondent |
KLS-Martin L.P. |
11201 Saint Johns Industrial Parkway S |
Jacksonville,
FL
32246
|
|
Correspondent Contact |
Katie Rutland |
Regulation Number | 882.4310
|
Classification Product Code |
|
Date Received | 10/15/2018 |
Decision Date | 07/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|