The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Forcetriad.
Device ID | K102913 |
510k Number | K102913 |
Device Name: | FORCETRIAD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 LONGBOW DRIVE Boulder, CO 80301 |
Contact | Ben Cordileone |
Correspondent | Ben Cordileone COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 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 | 2010-10-01 |
Decision Date | 2011-05-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521031913 | K102913 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FORCETRIAD 78717207 3349710 Live/Registered |
COVIDIEN AG 2005-09-21 |
FORCETRIAD 78717203 3349709 Dead/Cancelled |
COVIDIEN AG 2005-09-21 |