| Device Classification Name |
Instrument, Diamond, Dental
|
| 510(k) Number |
K885233 |
| Device Name |
NOVA DIAMOND |
| Applicant |
| Microcopy, Div. Neo-Flo, Inc. |
| 3120 Moon Station Rd. |
|
Kennesaw,
GA
30144
|
|
| Applicant Contact |
MAASS, JR. |
| Correspondent |
| Microcopy, Div. Neo-Flo, Inc. |
| 3120 Moon Station Rd. |
|
Kennesaw,
GA
30144
|
|
| Correspondent Contact |
MAASS, JR. |
| Regulation Number | 872.4535 |
| Classification Product Code |
|
| Date Received | 12/20/1988 |
| Decision Date | 02/13/1989 |
| 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
|
|
|