Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K000778 |
Device Name |
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 |
Applicant |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Applicant Contact |
BRUCE PROTHRO |
Correspondent |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Correspondent Contact |
BRUCE PROTHRO |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/10/2000 |
Decision Date | 05/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|