| Device Classification Name |
Dressing, Wound, Occlusive
|
| 510(k) Number |
K020781 |
| Device Name |
WET CHAMBER |
| Applicant |
| Kinetic Concepts, Inc. |
| P.O. Box 659508 |
|
San Antonio,
TX
78265 -9508
|
|
| Applicant Contact |
JUITH A HARBOUR |
| Correspondent |
| Kinetic Concepts, Inc. |
| P.O. Box 659508 |
|
San Antonio,
TX
78265 -9508
|
|
| Correspondent Contact |
JUITH A HARBOUR |
| Regulation Number | 878.4020 |
| Classification Product Code |
|
| Date Received | 03/11/2002 |
| Decision Date | 05/06/2002 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|