Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K020919 |
Device Name |
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 |
Applicant |
ATRICURE, INC. |
6033 SCHUMACHER PARK DR. |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
MARK L FRIEDMAN |
Correspondent |
ATRICURE, INC. |
6033 SCHUMACHER PARK DR. |
WEST CHESTER,
OH
45069
|
|
Correspondent Contact |
MARK L FRIEDMAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/21/2002 |
Decision Date | 04/19/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|