Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K041285 |
Device Name |
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
Applicant |
GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS |
CARDIFF,
GB
CF3 0LT
|
|
Applicant Contact |
ANDREW DZIMITROWICZ |
Correspondent |
GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS |
CARDIFF,
GB
CF3 0LT
|
|
Correspondent Contact |
ANDREW DZIMITROWICZ |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/13/2004 |
Decision Date | 09/10/2004 |
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
|