Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K162914 |
Device Name |
VenaCure EVLT NeverTouch Procedure Kit |
Applicant |
AngioDynamics, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Applicant Contact |
Robin Fuller |
Correspondent |
AngioDynamics, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Robin Fuller |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/17/2016 |
Decision Date | 11/16/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|