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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K083769
Device Name MODIFICATION TO URESTA PESSARY
Applicant
Eastmed, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact ROSHANA AHMED
Correspondent
Eastmed, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact ROSHANA AHMED
Regulation Number884.3575
Classification Product Code
HHW  
Date Received12/18/2008
Decision Date 01/14/2009
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
Predetermined Change
Control Plan Authorized		 No
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