Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K021500 |
Device Name |
VACUUM ASSISTED CLOSURE |
Applicant |
KINETIC CONCEPTS, INC. |
P.O. BOX 659508 |
SAN ANTONIO,
TX
78265 -9508
|
|
Applicant Contact |
WILLIAM H QUIRK |
Correspondent |
KINETIC CONCEPTS, INC. |
P.O. BOX 659508 |
SAN ANTONIO,
TX
78265 -9508
|
|
Correspondent Contact |
WILLIAM H QUIRK |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 05/09/2002 |
Decision Date | 12/20/2002 |
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
|