| 510(k) Number |
K843049 |
| Device Name |
CURING LIGHT |
| Applicant |
| Penn-Med Technology, Inc. |
| P.O. Box 71 |
|
West Conshohocken ,
PA
19428
|
|
| Applicant Contact |
ART KNOPP |
| Correspondent |
| Penn-Med Technology, Inc. |
| P.O. Box 71 |
|
West Conshohocken ,
PA
19428
|
|
| Correspondent Contact |
ART KNOPP |
| Date Received | 08/03/1984 |
| Decision Date | 04/12/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|