Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K950619 |
Device Name |
BIODERM MEDICAL 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 | 02/10/1995 |
Decision Date | 04/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|