| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K894569 |
| Device Name |
MEDPRIDE LATEX EXAMINATION GLOVES |
| Applicant |
| Transcorp |
| 40 Dogwood Dr. |
|
Chester,
NJ
07930
|
|
| Applicant Contact |
ROBERT KENNEDY |
| Correspondent |
| Transcorp |
| 40 Dogwood Dr. |
|
Chester,
NJ
07930
|
|
| Correspondent Contact |
ROBERT KENNEDY |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 07/21/1989 |
| Decision Date | 08/24/1989 |
| 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
|
|
|