| Device Classification Name |
Dressing, Wound, Occlusive
|
| 510(k) Number |
K864688 |
| Device Name |
ARNOLD-KING PRESSURE DRESSING |
| Applicant |
| Angiosystems, Inc. |
| 1980-D Parker Ct. |
|
Stone Mountain,
GA
30087
|
|
| Applicant Contact |
DAVID L HOPKINS |
| Correspondent |
| Angiosystems, Inc. |
| 1980-D Parker Ct. |
|
Stone Mountain,
GA
30087
|
|
| Correspondent Contact |
DAVID L HOPKINS |
| Regulation Number | 878.4020 |
| Classification Product Code |
|
| Date Received | 12/02/1986 |
| Decision Date | 01/12/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|