CONCEIVEX LATEX-FREE SEMEN COLLECTOR


Device Classification Name

kit, conception-assist, home use

510(k) Number K080752
Device Name CONCEIVEX LATEX-FREE SEMEN COLLECTOR
Applicant
CONCEIVEX INC.
2600 mullinix mill road
mt. airy, 
MD 
21771 -0031

Applicant Contact blix winston
Correspondent
CONCEIVEX INC.
2600 mullinix mill road
mt. airy, 
MD 
21771 -0031

Correspodent Contact blix winston
Regulation Number 884.5250
Classification Product Code
OBB  
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