| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K952367 |
| Device Name |
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE |
| Applicant |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Correspondent |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 05/11/1995 |
| Decision Date | 07/05/1995 |
| 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
|
|
|