FEMCHEC PRESSURE MANAGEMET DEVICE


Device Classification Name

cannula, manipulator/injector, uterine

510(k) Number K110993
Device Name FEMCHEC PRESSURE MANAGEMET DEVICE
Applicant
FEMASYS INC.
5000 research court ste .100
suwanee, 
GA 
30024

Applicant Contact lisa peacock
Correspondent
FEMASYS INC.
5000 research court ste .100
suwanee, 
GA 
30024

Correspodent Contact lisa peacock
Classification Product Code
LKF  
Date Received 04/08/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No