Device Classification Name |
kit, conception-assist, home use |
|||
---|---|---|---|---|
510(k) Number | K080752 | |||
Device Name | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | |||
Applicant |
|
|||
Applicant Contact | blix winston | |||
Correspondent |
|
|||
Correspodent Contact | blix winston | |||
Regulation Number | 884.5250 | |||
Classification Product Code |
|
|||
Date Received | 03/17/2008 | |||
Decision Date | 05/14/2008 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Obstetrics/Gynecology |
|||
510k Review Panel |
Obstetrics/Gynecology |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |