510(k) K083769

MODIFICATION TO URESTA PESSARY by Eastmed, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2009
Date Received
December 18, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type