Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K083357 |
Device Name |
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
Applicant |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
CHRISTY H OVIATT |
Correspondent |
KCI USA, INC. |
6203 FARINON DR. |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
CHRISTY H OVIATT |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 11/13/2008 |
Decision Date | 03/04/2009 |
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
|