| Device Classification Name |
Bandage, Liquid
|
| 510(k) Number |
K953131 |
| Device Name |
EXUSORB STERILE ABSORBENT |
| Applicant |
| O.R. Resources, Inc. |
| 212 Briny Ave., Suite A-4 |
|
Pompano Beach,
FL
33062
|
|
| Applicant Contact |
ALFRED J LINDSEY |
| Correspondent |
| O.R. Resources, Inc. |
| 212 Briny Ave., Suite A-4 |
|
Pompano Beach,
FL
33062
|
|
| Correspondent Contact |
ALFRED J LINDSEY |
| Regulation Number | 880.5090 |
| Classification Product Code |
|
| Date Received | 07/06/1995 |
| Decision Date | 09/08/1995 |
| 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
|
|
|