| Device Classification Name |
Cap, Cervical
|
| 510(k) Number |
K884696 |
| Device Name |
RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET |
| Applicant |
| Laboratoire Ccd C/O Washington Regulatory Services |
| 23 Welisewitz Rd. |
|
Ringoes,
NJ
08551
|
|
| Applicant Contact |
RANDOLPH L COOKE |
| Correspondent |
| Laboratoire Ccd C/O Washington Regulatory Services |
| 23 Welisewitz Rd. |
|
Ringoes,
NJ
08551
|
|
| Correspondent Contact |
RANDOLPH L COOKE |
| Regulation Number | 884.5250 |
| Classification Product Code |
|
| Date Received | 11/09/1988 |
| Decision Date | 01/27/1989 |
| 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
|
|
|