Device Classification Name |
Electrode, Electrosurgical
|
510(k) Number |
K050923 |
Device Name |
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR |
Applicant |
CONMED LINVATEC |
11311 CONCEPT BOULEVARD |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
ELIZABETH PAUL |
Correspondent |
CONMED LINVATEC |
11311 CONCEPT BOULEVARD |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
ELIZABETH PAUL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2005 |
Decision Date | 05/18/2005 |
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
|
Recalls |
CDRH Recalls
|