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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Personal Lubricant Ring
510(k) Number K203377
Device Name VR101 Lubricating Intravaginal Ring
Applicant
J3 Bioscience, Inc.
825 N. 300 W., Suite N231
Salt Lake City,  UT  84103
Applicant Contact R. Tyler McCabe
Correspondent
J3 Bioscience, Inc.
825 N. 300 W., Suite N231
Salt Lake City,  UT  84103
Correspondent Contact R. Tyler McCabe
Regulation Number884.5300
Classification Product Code
QPD  
Date Received11/17/2020
Decision Date 05/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02029053
NCT04288752
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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