ENDOSIZE
System, Image Processing, Radiological
THERENVA SAS
The following data is part of a premarket notification filed by Therenva Sas with the FDA for Endosize.
Pre-market Notification Details
| Device ID | K141475 |
| 510k Number | K141475 |
| Device Name: | ENDOSIZE |
| Classification | System, Image Processing, Radiological |
| Applicant | THERENVA SAS 2 RUE HENRI LE GUILLOUX Rennes, FR 35000 |
| Contact | Cemil Goksu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-06-04 |
| Decision Date | 2014-07-31 |
| Summary: | summary |
Trademark Results [ENDOSIZE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSIZE 79144232 4611902 Live/Registered |
THERENVA 2013-11-19 |
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