| 510(k) Number |
K842691 |
| Device Name |
HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY |
| Applicant |
| Health Technology Services |
| 747 Church Rd.-Unit B5 |
|
Elmhurst ,
IL
60126 -
|
|
| Applicant Contact |
JACK KUYKENDALL |
| Correspondent |
| Health Technology Services |
| 747 Church Rd.-Unit B5 |
|
Elmhurst ,
IL
60126 -
|
|
| Correspondent Contact |
JACK KUYKENDALL |
| Date Received | 07/11/1984 |
| Decision Date | 11/05/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|