| Device Classification Name |
Vinyl Patient Examination Glove
|
| 510(k) Number |
K891941 |
| Device Name |
PATIENT EXAMINATION GLOVES (VINYL) |
| Applicant |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Applicant Contact |
VARUN SONI |
| Correspondent |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Correspondent Contact |
VARUN SONI |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 03/28/1989 |
| Decision Date | 05/08/1989 |
| 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
|
|
|