Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K120033 |
Device Name |
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT |
Applicant |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
Shannon Scott |
Correspondent |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
Shannon Scott |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 01/04/2012 |
Decision Date | 05/31/2012 |
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
|