Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K102470 |
FOIA Releasable 510(k) |
K102470
|
Device Name |
LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER |
Applicant |
COVIDIEN, FORMERLY VALLEYLAB, |
5920 LONGBOW DRIVE |
BOULDER,
CO
80301
|
|
Applicant Contact |
DAVID M HORTON |
Correspondent |
COVIDIEN, FORMERLY VALLEYLAB, |
5920 LONGBOW DRIVE |
BOULDER,
CO
80301
|
|
Correspondent Contact |
DAVID M HORTON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/30/2010 |
Decision Date | 02/07/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|