Device Classification Name |
Tracking, Soft Tissue, Intraoperative
|
510(k) Number |
K143024 |
Device Name |
CAS-One Liver |
Applicant |
CAScination AG |
Stauffacherstrasse 78 |
Bern,
CH
3014
|
|
Applicant Contact |
Matthias Peterhans |
Correspondent |
CAScination AG |
Stauffacherstrasse 78 |
Bern,
CH
3014
|
|
Correspondent Contact |
Matthias Peterhans |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 10/21/2014 |
Decision Date | 04/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|