FDA 510(k) Application Details - K081385

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K081385
Device Name	Pessary, Vaginal
Applicant	EASTMED INC. 4 INNOVATION DRIVE DUNDAS L9H 7P3 CA Other 510(k) Applications for this Company
Contact	SHIRLEY FURESZ Other 510(k) Applications for this Contact
Regulation Number	884.3575   More FDA Info for this Regulation Number
Classification Product Code	HHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2008
Decision Date	10/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review