Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K951561 |
Device Name |
DYNASORB |
Applicant |
DERMARX CORP. |
284 JACKSON ST. |
DENVER,
CO
80206
|
|
Applicant Contact |
MARYANNE CARROLL |
Correspondent |
DERMARX CORP. |
284 JACKSON ST. |
DENVER,
CO
80206
|
|
Correspondent Contact |
MARYANNE CARROLL |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 04/05/1995 |
Decision Date | 09/01/1995 |
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
|
|
|