The following data is part of a premarket notification filed by Therenva Sas with the FDA for Endosize.
Device ID | K160376 |
510k Number | K160376 |
Device Name: | EndoSize |
Classification | System, Image Processing, Radiological |
Applicant | Therenva SAS 4 Rue Jean Jaures Rennes, FR 35000 |
Contact | Cemil Goksu |
Correspondent | Cemil Goksu Therenva SAS 4 Rue Jean Jaures Rennes, FR 35000 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-10 |
Decision Date | 2016-04-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENDOSIZE 79144232 4611902 Live/Registered |
THERENVA 2013-11-19 |