| Device Classification Name |
Dressing, Wound And Burn, Occlusive
|
| 510(k) Number |
K924008 |
| Device Name |
STERILE FILM WOUND DRESSING |
| Applicant |
| Innovative Technology , Ltd. |
| 227 Eagle St. |
| Newmarket |
|
Ontario L3y 1j8,
CA
|
|
| Applicant Contact |
DIANE J MITCHELL |
| Correspondent |
| Innovative Technology , Ltd. |
| 227 Eagle St. |
| Newmarket |
|
Ontario L3y 1j8,
CA
|
|
| Correspondent Contact |
DIANE J MITCHELL |
| Classification Product Code |
|
| Date Received | 08/10/1992 |
| Decision Date | 11/24/1992 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|