The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Blunt Tip, Sealer/divider, Nano-coated.
Device ID | K162941 |
510k Number | K162941 |
Device Name: | Ligasure Blunt Tip, Sealer/Divider, 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-21 |
Decision Date | 2016-11-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521705897 | K162941 | 000 |
20884521705880 | K162941 | 000 |
10884521705876 | K162941 | 000 |