| 510(k) Number |
K851575 |
| Device Name |
DR. BRUNO LNAGE MINI PHOTOMETER |
| Applicant |
| Texas Medical Products, Inc. |
| 16811 El Camino Real |
| Suite 203 |
|
Houston,
TX
77058
|
|
| Applicant Contact |
JOYCE HEINEICH |
| Correspondent |
| Texas Medical Products, Inc. |
| 16811 El Camino Real |
| Suite 203 |
|
Houston,
TX
77058
|
|
| Correspondent Contact |
JOYCE HEINEICH |
| Date Received | 04/17/1985 |
| Decision Date | 10/18/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|