Device Classification Name |
lamp, surgical
|
510(k) Number |
K041681 |
Device Name |
ATRICURE DISSECTOR |
Applicant |
ATRICURE, INC. |
6033 SCHUMACHER PARK DR. |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
MARK JOB |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 06/21/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|