| Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
| 510(k) Number |
K882590 |
| Device Name |
VIADERM |
| Applicant |
| Applied Biomedical Sciences |
| 320 Golden Shore Dr. |
| Suite 300 |
|
Long Beach,
CA
90802
|
|
| Applicant Contact |
SHERYL OSBORNE |
| Correspondent |
| Applied Biomedical Sciences |
| 320 Golden Shore Dr. |
| Suite 300 |
|
Long Beach,
CA
90802
|
|
| Correspondent Contact |
SHERYL OSBORNE |
| Classification Product Code |
|
| Date Received | 06/23/1988 |
| Decision Date | 10/07/1988 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|