The following data is part of a premarket notification filed by Covidien with the FDA for Force Triverse Electrosugical Device, Holster, 10-foot, Force Triverse Electrosurgical Device, Holster, 15-foot.
Device ID | K150735 |
510k Number | K150735 |
Device Name: | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | COVIDIEN 5920 LONGBOW DRIVE Boulder, CO 80301 |
Contact | Nancy Sauer |
Correspondent | Nancy Sauer 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 | 2015-03-20 |
Decision Date | 2015-08-04 |
Summary: | summary |