| 510(k) Number |
K837046 |
| Device Name |
AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEM |
| Applicant |
| Technicare Corp. |
| 29100 Aurora Rd. |
|
Solon,
OH
44139
|
|
| Correspondent |
| Technicare Corp. |
| 29100 Aurora Rd. |
|
Solon,
OH
44139
|
|
| Date Received | 01/10/1983 |
| Decision Date | 04/01/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|