Device Classification Name |
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
|
510(k) Number |
K122611 |
Device Name |
COOLRAIL LINEAR PEN MODEL MCRI |
Applicant |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
JIM LUCKY, RAC |
Correspondent |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE |
WEST CHESTER,
OH
45069
|
|
Correspondent Contact |
JIM LUCKY, RAC |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/27/2012 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|