| 510(k) Number |
K863336 |
| Device Name |
CORDIPAK ANGIOGRAPHY TRAY |
| Applicant |
| Angi-Pak Corp. |
| 13780 SW 73 Ct. |
|
Miami,
FL
33158
|
|
| Applicant Contact |
STEWART FINCH |
| Correspondent |
| Angi-Pak Corp. |
| 13780 SW 73 Ct. |
|
Miami,
FL
33158
|
|
| Correspondent Contact |
STEWART FINCH |
| Date Received | 08/28/1986 |
| Decision Date | 09/12/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|