The following data is part of a premarket notification filed by Elliquence Llc with the FDA for Elliquence Electrodes.
Device ID | K142410 |
510k Number | K142410 |
Device Name: | Elliquence Electrodes |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ELLIQUENCE LLC 2455 Grand Avenue Baldwin, NY 11510 |
Contact | Paul D Buhrke |
Correspondent | Paul D Buhrke ELLIQUENCE LLC 2455 Grand Avenue Baldwin, NY 11510 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-28 |
Decision Date | 2015-10-30 |
Summary: | summary |