| Device Classification Name |
Thermometer, Clinical Mercury
|
| 510(k) Number |
K893602 |
| Device Name |
GLASS MERCURY FILLED THERMOMETERS |
| Applicant |
| Smith & Nephew United, Inc. |
| 11775 Starkley Rd. |
| P.O.Box 1970 |
|
Largo,
FL
34649
|
|
| Applicant Contact |
JIM IRVIN |
| Correspondent |
| Smith & Nephew United, Inc. |
| 11775 Starkley Rd. |
| P.O.Box 1970 |
|
Largo,
FL
34649
|
|
| Correspondent Contact |
JIM IRVIN |
| Regulation Number | 880.2920 |
| Classification Product Code |
|
| Date Received | 05/15/1989 |
| Decision Date | 08/08/1989 |
| 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
|
|
|