| 510(k) Number |
K828325 |
| Device Name |
YOSHIDA/KAYCOR X-70 X-RAY UNIT |
| Applicant |
| The Yoshida Dental Mfg. Co., Ltd. |
| 1-3-6, Kotobashi, Sumida-Ku |
|
Tokyo,
JP
130 8516
|
|
| Correspondent |
| The Yoshida Dental Mfg. Co., Ltd. |
| 1-3-6, Kotobashi, Sumida-Ku |
|
Tokyo,
JP
130 8516
|
|
| Date Received | 09/28/1982 |
| Decision Date | 10/21/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|