| Device Classification Name |
Sampler, Endocervical
|
| 510(k) Number |
K882404 |
| Device Name |
KEVOR-CURETTE |
| Applicant |
| Euro-Med Intl. |
| P.O. Box 1367 |
|
Alameda,
CA
94501
|
|
| Applicant Contact |
KARL HALL |
| Correspondent |
| Euro-Med Intl. |
| P.O. Box 1367 |
|
Alameda,
CA
94501
|
|
| Correspondent Contact |
KARL HALL |
| Regulation Number | 884.1050 |
| Classification Product Code |
|
| Date Received | 06/10/1988 |
| Decision Date | 07/08/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|