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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vaginal
510(k) Number K231430
Device Name Intimate Rose Vaginal Dilators
Applicant
Plus EV Holdings dba Intimate Rose
1419 Murray Street
North Kansas City,  MO  64116
Applicant Contact Aaron Wilt
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number884.3900
Classification Product Code
HDX  
Date Received05/17/2023
Decision Date 06/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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