Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
510(k) Number |
K061711 |
FOIA Releasable 510(k) |
K061711
|
Device Name |
OASIS WOUND MATRIX |
Applicant |
COOK BIOTECH, INC. |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Applicant Contact |
PERRY W GUINN |
Correspondent |
COOK BIOTECH, INC. |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Correspondent Contact |
PERRY W GUINN |
Classification Product Code |
|
Date Received | 06/19/2006 |
Decision Date | 07/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|