| Device Classification Name |
Thermometer, Clinical Mercury
|
| 510(k) Number |
K923225 |
| Device Name |
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME |
| Applicant |
| Lorrex Health Products |
| 301 Penhorn Ave. |
|
Secaucus,
NJ
07094
|
|
| Applicant Contact |
ERIC M MORALES |
| Correspondent |
| Lorrex Health Products |
| 301 Penhorn Ave. |
|
Secaucus,
NJ
07094
|
|
| Correspondent Contact |
ERIC M MORALES |
| Regulation Number | 880.2920 |
| Classification Product Code |
|
| Date Received | 07/01/1992 |
| Decision Date | 06/08/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|