The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Blunt Tip Sealer/divider.
Device ID | K142929 |
510k Number | K142929 |
Device Name: | Ligasure Blunt Tip Sealer/Divider |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | COVIDIEN 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Celso Duran |
Correspondent | Celso Duran COVIDIEN 5920 LONGBOW DR. 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 | 2014-10-09 |
Decision Date | 2015-01-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521210868 | K142929 | 000 |
20884521209265 | K142929 | 000 |