Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K072332 |
Device Name |
VARI-LASE WIRE FIBER |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
DEBORAH NEYMARK |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
DEBORAH NEYMARK |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/20/2007 |
Decision Date | 01/10/2008 |
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
|
Recalls |
CDRH Recalls
|