| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K892986 |
| Device Name |
PATIENT EXAMINATION GLOVE |
| Applicant |
| Larkspur Consulting Co. |
| 2169 Francisco Blvd., Suite J- |
| 6 |
|
San Rafael,
CA
94901
|
|
| Applicant Contact |
DUANE MENTING |
| Correspondent |
| Larkspur Consulting Co. |
| 2169 Francisco Blvd., Suite J- |
| 6 |
|
San Rafael,
CA
94901
|
|
| Correspondent Contact |
DUANE MENTING |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 04/12/1989 |
| Decision Date | 07/14/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|