Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K022543 |
Device Name |
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM |
Applicant |
ARTHROCARE CORP. |
680 VAQUEROS AVE. |
SUNNYVALE,
CA
94085 -3523
|
|
Applicant Contact |
VALERIE DEFIESTA-NG |
Correspondent |
ARTHROCARE CORP. |
680 VAQUEROS AVE. |
SUNNYVALE,
CA
94085 -3523
|
|
Correspondent Contact |
VALERIE DEFIESTA-NG |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2002 |
Decision Date | 08/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|