| Device Classification Name |
Surgeon'S Gloves
|
| 510(k) Number |
K890289 |
| Device Name |
DIVERSI-MED STERILE LATEX SURGEON'S GLOVES |
| Applicant |
| Diversi Group, Inc. |
| 222 W. Hutchison |
| Suite 1a |
|
San Marcos,
TX
78666
|
|
| Applicant Contact |
WILLIAM T KNOWLES |
| Correspondent |
| Diversi Group, Inc. |
| 222 W. Hutchison |
| Suite 1a |
|
San Marcos,
TX
78666
|
|
| Correspondent Contact |
WILLIAM T KNOWLES |
| Regulation Number | 878.4460 |
| Classification Product Code |
|
| Date Received | 01/19/1989 |
| Decision Date | 05/05/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|