Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K063426 |
Device Name |
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
Applicant |
KCI USA, INC. |
8023 VANTAGE DR. |
SAN ANTONIO,
TX
78230 -4726
|
|
Applicant Contact |
VERONIQUE SMITH |
Correspondent |
KCI USA, INC. |
8023 VANTAGE DR. |
SAN ANTONIO,
TX
78230 -4726
|
|
Correspondent Contact |
VERONIQUE SMITH |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 11/13/2006 |
Decision Date | 12/13/2006 |
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
|