Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K051287 |
Device Name |
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
LINDA BUSKLEIN |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
LINDA BUSKLEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/18/2005 |
Decision Date | 07/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|