Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K093526 |
Device Name |
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
Applicant |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
6203 FARINON DRIVE |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
RANDALL WHEELAND |
Correspondent |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
6203 FARINON DRIVE |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
RANDALL WHEELAND |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 11/16/2009 |
Decision Date | 03/10/2010 |
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
|