The following data is part of a premarket notification filed by Ellusa, Llc with the FDA for Ellusa Reusable Bipolar Cable.
|Device Name:||Ellusa Reusable Bipolar Cable|
|Classification||Electrosurgical, Cutting & Coagulation & Accessories|
|Applicant||Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510|
Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510
|CFR Regulation Number||878.4400 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|