| 510(k) Number |
K827410 |
| Device Name |
LITERATURE ON THE SONADENT |
| Applicant |
| L&R Mfg. Co., Inc. |
| 577 Elm St. |
|
Kearny,
NJ
07032
|
|
| Correspondent |
| L&R Mfg. Co., Inc. |
| 577 Elm St. |
|
Kearny,
NJ
07032
|
|
| Date Received | 04/30/1982 |
| Decision Date | 06/04/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|