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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 K220035
Device Name Milli Vaginal Dilator
Applicant
Materna Medical
2495 Hospital Dr., Suite 300
Mountain View,  CA  94040
Applicant Contact Kelly Ashfield
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.3900
Classification Product Code
HDX  
Date Received01/05/2022
Decision Date 02/27/2023
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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