| Device Classification Name |
System, Abortion, Vacuum
|
| 510(k) Number |
K873552 |
| Device Name |
CANNULA AND GENERAL PURPOSE ASPIRATOR |
| Applicant |
| Cosmedtech, Inc. |
| 25625 Minoa Dr. |
|
Mission Viejo,
CA
92691
|
|
| Applicant Contact |
JOHN M NORDLUND |
| Correspondent |
| Cosmedtech, Inc. |
| 25625 Minoa Dr. |
|
Mission Viejo,
CA
92691
|
|
| Correspondent Contact |
JOHN M NORDLUND |
| Regulation Number | 884.5070 |
| Classification Product Code |
|
| Date Received | 08/10/1987 |
| Decision Date | 11/25/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|