The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Exact Dissector, Nano-coated.
Device ID | K173281 |
510k Number | K173281 |
Device Name: | LigaSure Exact Dissector, Nano-coated |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
Contact | Celso Duran |
Correspondent | Celso Duran Covidien 5920 Longbow Drive Boulder, CO 80301 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-16 |
Decision Date | 2018-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521741093 | K173281 | 000 |