Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K162790 |
Device Name |
V.A.C.ULTA Negative Pressure Wound Therapy System |
Applicant |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
6203 Farinon Drive |
San Antonio,
TX
78249
|
|
Applicant Contact |
Margaret Marsh |
Correspondent |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
6203 Farinon Drive |
San Antonio,
TX
78249
|
|
Correspondent Contact |
Margaret Marsh |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/04/2016 |
Decision Date | 01/26/2017 |
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
|