| 510(k) Number |
K842371 |
| Device Name |
LEE SYRINGE |
| Applicant |
| Peter F. Lee, Inc. |
| 5200 W. 73rd. |
|
Minneapolis ,
MN
55435
|
|
| Applicant Contact |
PETER F LEE |
| Correspondent |
| Peter F. Lee, Inc. |
| 5200 W. 73rd. |
|
Minneapolis ,
MN
55435
|
|
| Correspondent Contact |
PETER F LEE |
| Date Received | 06/15/1984 |
| Decision Date | 01/14/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|