| 510(k) Number |
K883686 |
| Device Name |
STERILE EMPTY GLASS VIALS |
| Applicant |
| Farris Laboratories, Inc. |
| P.O. Box 948 |
|
Desoto,
TX
75123 -0948
|
|
| Applicant Contact |
JOHN R FARRIS |
| Correspondent |
| Farris Laboratories, Inc. |
| P.O. Box 948 |
|
Desoto,
TX
75123 -0948
|
|
| Correspondent Contact |
JOHN R FARRIS |
| Classification Product Code |
|
| Date Received | 08/29/1988 |
| Decision Date | 09/23/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|