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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 K233548
Device Name Uresta®
Applicant
Resilia, Inc.
644 Main St.
Suite S400, P.O. Box 1368
Moncton,  CA E1C 1E2
Applicant Contact Sam Imbeault
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number884.3575
Classification Product Code
HHW  
Date Received11/03/2023
Decision Date 04/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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