| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K894226 |
| Device Name |
SILASTIC SOFT SHEETING |
| Applicant |
| Dow Corning Wright |
| P.O. Box 100 |
|
Arlington,
TN
38002
|
|
| Applicant Contact |
MICKI ROY |
| Correspondent |
| Dow Corning Wright |
| P.O. Box 100 |
|
Arlington,
TN
38002
|
|
| Correspondent Contact |
MICKI ROY |
| Classification Product Code |
|
| Date Received | 06/19/1989 |
| Decision Date | 01/03/1990 |
| 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
|
|
|