| Device Classification Name |
Accessories, Catheter
|
| 510(k) Number |
K893406 |
| Device Name |
DESERET PRN ADAPTER |
| Applicant |
| Deseret Medical, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Applicant Contact |
CHARLES J WELLE |
| Correspondent |
| Deseret Medical, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Correspondent Contact |
CHARLES J WELLE |
| Regulation Number | 878.4200 |
| Classification Product Code |
|
| Date Received | 05/02/1989 |
| Decision Date | 06/22/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|