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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 K211959
Device Name Milli Vaginal Dilator
Materna Medical
2495 Hospital Drive Suite 300
Mountain View,  CA  94040
Applicant Contact Kelly Ashfield
Experien Group, LLC
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-Ng
Regulation Number884.3900
Classification Product Code
Date Received06/24/2021
Decision Date 12/01/2021
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