URESTA PESSARY


Device Classification Name

pessary, vaginal

510(k) Number K081385
Device Name URESTA PESSARY
Applicant
EASTMED INC.
4 innovation drive
dundas, 

CA

l9h 7p3

Applicant Contact shirley furesz
Correspondent
EASTMED INC.
4 innovation drive
dundas, 

CA

l9h 7p3

Correspodent Contact shirley furesz
Regulation Number 884.3575
Classification Product Code
HHW  
Date Received 05/16/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No