| Device Classification Name |
Airbrush
|
| 510(k) Number |
K993182 |
| Device Name |
DISPOPROPHY |
| Applicant |
| Kis Products |
| 2318 Sea Island Dr. |
|
Fort Lauderdale,
FL
33301
|
|
| Applicant Contact |
REUBEN HERTZ |
| Correspondent |
| Kis Products |
| 2318 Sea Island Dr. |
|
Fort Lauderdale,
FL
33301
|
|
| Correspondent Contact |
REUBEN HERTZ |
| Regulation Number | 872.6080 |
| Classification Product Code |
|
| Date Received | 09/23/1999 |
| Decision Date | 08/06/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|