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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 K232525
Device Name Yoni.Fit Bladder Support
Applicant
Watkins-Conti Products, Inc.
3841 E. Danforth Rd., Suite 109
Edmond,  OK  78084
Applicant Contact Allison L Watkins
Correspondent
Hyman, Phelps & McNamara, PC
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne R. Lenz
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/21/2023
Decision Date 05/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03978741
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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