Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K970600 |
Device Name |
DERMAMEND FOAM ISLAND DRESSING |
Applicant |
DERMARX CORP. |
400 SOUTH COLORADO BLVD.,#420 |
DENVER,
CO
80222
|
|
Applicant Contact |
MARYANNE CARROLL |
Correspondent |
DERMARX CORP. |
400 SOUTH COLORADO BLVD.,#420 |
DENVER,
CO
80222
|
|
Correspondent Contact |
MARYANNE CARROLL |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 02/18/1997 |
Decision Date | 05/08/1997 |
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
|
|
|