| 510(k) Number |
K854072 |
| Device Name |
JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR- |
| Applicant |
| Dexide, Inc. |
| P.O. Box 185789 |
|
Fort Worth,
TX
76181
|
|
| Applicant Contact |
MARY K BRUCH |
| Correspondent |
| Dexide, Inc. |
| P.O. Box 185789 |
|
Fort Worth,
TX
76181
|
|
| Correspondent Contact |
MARY K BRUCH |
| Date Received | 10/04/1985 |
| Decision Date | 11/15/1985 |
| 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
|
|
|