| Device Classification Name |
Injector And Syringe, Angiographic
|
| 510(k) Number |
K903495 |
| Device Name |
LIQUID DETECTOR |
| Applicant |
| Life-Tech Intl., Inc. |
| P.O. Box 36221 |
|
Houston,
TX
77236
|
|
| Applicant Contact |
ALFRED C COATS |
| Correspondent |
| Life-Tech Intl., Inc. |
| P.O. Box 36221 |
|
Houston,
TX
77236
|
|
| Correspondent Contact |
ALFRED C COATS |
| Regulation Number | 870.1650 |
| Classification Product Code |
|
| Date Received | 08/03/1990 |
| Decision Date | 10/05/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|