| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|