| Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
| 510(k) Number |
K950281 |
| Device Name |
MESH MATRIX WOUND DRESSING |
| Applicant |
| Brennen Medical, Inc. |
| 1290 Hammond Rd. |
|
St. Paul,
MN
55110
|
|
| Applicant Contact |
JEFFREY M WILLIAMS |
| Correspondent |
| Brennen Medical, Inc. |
| 1290 Hammond Rd. |
|
St. Paul,
MN
55110
|
|
| Correspondent Contact |
JEFFREY M WILLIAMS |
| Classification Product Code |
|
| Date Received | 01/24/1995 |
| Decision Date | 04/13/1995 |
| 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
|