The following data is part of a premarket notification filed by Nissha Medical Technologies Sas with the FDA for Endotube.
Device ID | K203350 |
510k Number | K203350 |
Device Name: | ENDOtube |
Classification | Endoscopic Irrigation/suction System |
Applicant | Nissha Medical Technologies SAS ZA Des Boutries 12 Rue Des Cayennes Conflans Ste Honorine, FR 78700 |
Contact | Roch Mignot |
Correspondent | Roch Mignot Nissha Medical Technologies SAS ZA Des Boutries 12 Rue Des Cayennes Conflans Ste Honorine, FR 78700 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-13 |
Decision Date | 2021-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOTUBE 87944328 not registered Dead/Abandoned |
Graphic Controls Acquisition Corp. 2018-06-01 |