| Device Classification Name |
Light, Operating, Dental
|
| 510(k) Number |
K925629 |
| Device Name |
ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT |
| Applicant |
| Den-Tal-Ez Mfg Co., Inc. |
| 1816 Colonial Village Ln. |
|
Lancaster,
PA
17601
|
|
| Applicant Contact |
WILLIAM A.LAMBERTSON |
| Correspondent |
| Den-Tal-Ez Mfg Co., Inc. |
| 1816 Colonial Village Ln. |
|
Lancaster,
PA
17601
|
|
| Correspondent Contact |
WILLIAM A.LAMBERTSON |
| Regulation Number | 872.4630 |
| Classification Product Code |
|
| Date Received | 11/06/1992 |
| Decision Date | 11/23/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|