Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K051142 |
Device Name |
ANGIODYNAMICS TUMESCENT INFUSION DEVICE |
Applicant |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
TERI JUCKETT |
Correspondent |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
TERI JUCKETT |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/04/2005 |
Decision Date | 07/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|