| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K941688 |
| Device Name |
INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS |
| Applicant |
| Innovative Technologies , Ltd. |
| Rd. Three |
| Winsford Industrial Estate |
|
Winsford, Cheshire,
GB
CW7 3PD
|
|
| Applicant Contact |
DIANE J MITCHELL |
| Correspondent |
| Innovative Technologies , Ltd. |
| Rd. Three |
| Winsford Industrial Estate |
|
Winsford, Cheshire,
GB
CW7 3PD
|
|
| Correspondent Contact |
DIANE J MITCHELL |
| Classification Product Code |
|
| Date Received | 04/06/1994 |
| Decision Date | 09/08/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|