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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 K253698
Device Name Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes
Applicant
Cooper Surgical
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Timothy Good
Correspondent
Cooper Surgical
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Timothy Good
Regulation Number884.3575
Classification Product Code
HHW  
Date Received11/24/2025
Decision Date 01/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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