Device Classification Name |
bandage, liquid
|
510(k) Number |
K982778 |
Device Name |
BIODERM FOAM WOUND DRESSING |
Applicant |
BIODERM, INC. |
P.O. BOX 4882 |
WHEATON,
IL
60189
|
|
Applicant Contact |
GEORGE WORTHLEY |
Correspondent |
BIODERM, INC. |
P.O. BOX 4882 |
WHEATON,
IL
60189
|
|
Correspondent Contact |
GEORGE WORTHLEY |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 08/07/1998 |
Decision Date | 10/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|