The following data is part of a premarket notification filed by Elliquence Llc. with the FDA for Cobbra Rf Tissue Dissector.
Device ID | K160041 |
510k Number | K160041 |
Device Name: | Cobbra RF Tissue Dissector |
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 | 2016-01-08 |
Decision Date | 2016-03-07 |
Summary: | summary |