The following data is part of a premarket notification filed by Cascination Ag with the FDA for Cas-one Liver.
Device ID | K143024 |
510k Number | K143024 |
Device Name: | CAS-One Liver |
Classification | Tracking, Soft Tissue, Intraoperative |
Applicant | CAScination AG Stauffacherstrasse 78 Bern, CH 3014 |
Contact | Matthias Peterhans |
Correspondent | Matthias Peterhans CAScination AG Stauffacherstrasse 78 Bern, CH 3014 |
Product Code | OEW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-21 |
Decision Date | 2015-04-28 |
Summary: | summary |