The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Curved, Small Jaw, Open Sealer/divider.
Device ID | K152286 |
510k Number | K152286 |
Device Name: | LigaSure Curved, Small Jaw, Open Sealer/Divider |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | COVIDIEN 5920 LONGBOW DRIVE Boulder, CO 80301 |
Contact | Dawn Tindall |
Correspondent | Dawn Tindall 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 | 2015-08-13 |
Decision Date | 2015-09-08 |
Summary: | summary |