| Device Classification Name |
Dressing, Wound And Burn, Occlusive
|
| 510(k) Number |
K915635 |
| Device Name |
CURITY VENTED DRESSING SYSTEM |
| Applicant |
| Kendall Healthcare Products Co. Div.Of Tyco Health |
| 15 Hampshire St. |
|
Mansfield,
MA
02048
|
|
| Applicant Contact |
PAUL EVANS |
| Correspondent |
| Kendall Healthcare Products Co. Div.Of Tyco Health |
| 15 Hampshire St. |
|
Mansfield,
MA
02048
|
|
| Correspondent Contact |
PAUL EVANS |
| Classification Product Code |
|
| Date Received | 12/17/1991 |
| Decision Date | 01/31/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|