Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K132741 |
Device Name |
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
Applicant |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
MELANIE AVILA |
Correspondent |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
MELANIE AVILA |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/03/2013 |
Decision Date | 11/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|