Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
510(k) Number |
K935189 |
Device Name |
E-Z DERM BIOSYNTHETIC 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 | 10/26/1993 |
Decision Date | 07/11/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|