| Device Classification Name |
Floss, Dental
|
| 510(k) Number |
K911701 |
| Device Name |
G-FLOSS & G-FLOSS II |
| Applicant |
| Implant Innovations International, Inc. |
| 1897 Palm Beach Lakes Blvd. |
| Suite 114 |
|
West Palm Beach,
FL
33409
|
|
| Applicant Contact |
WILLIAM G CONETY |
| Correspondent |
| Implant Innovations International, Inc. |
| 1897 Palm Beach Lakes Blvd. |
| Suite 114 |
|
West Palm Beach,
FL
33409
|
|
| Correspondent Contact |
WILLIAM G CONETY |
| Regulation Number | 872.6390 |
| Classification Product Code |
|
| Date Received | 04/16/1991 |
| Decision Date | 05/15/1991 |
| 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
|
|
|