| 510(k) Number |
K837430 |
| Device Name |
AUTO D OPTION |
| Applicant |
| Technicare Corp. |
| 29100 Aurora Rd. |
|
Solon,
OH
44139
|
|
| Correspondent |
| Technicare Corp. |
| 29100 Aurora Rd. |
|
Solon,
OH
44139
|
|
| Date Received | 04/29/1983 |
| Decision Date | 05/18/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|