Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K955531 |
Device Name |
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM |
Applicant |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Applicant Contact |
CHERYL L SHEA |
Correspondent |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Correspondent Contact |
CHERYL L SHEA |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/04/1995 |
Decision Date | 02/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|