Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K110225 |
Device Name |
ANGIODYNAMICS, INC. VENACURE 1470 LASER |
Applicant |
ANGIODYNAMICS, INC. |
14 PLAZA DRIVE |
LATHAM,
NY
12110
|
|
Applicant Contact |
TERI JUCKETT |
Correspondent |
ANGIODYNAMICS, INC. |
14 PLAZA DRIVE |
LATHAM,
NY
12110
|
|
Correspondent Contact |
TERI JUCKETT |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/25/2011 |
Decision Date | 05/13/2011 |
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
|