| 510(k) Number |
K837440 |
| Device Name |
UNKNOWN |
| Applicant |
| The S. S. White Co. |
| P.O. Box 100 |
|
Holmdel,
NJ
07733
|
|
| Correspondent |
| The S. S. White Co. |
| P.O. Box 100 |
|
Holmdel,
NJ
07733
|
|
| Date Received | 04/05/1983 |
| Decision Date | 06/10/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|