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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K230518
Device Name HydraDose Vaginal Suppositories
Applicant
MD Labs, LLC
780 Lakefield Rd., Suite H
Westlake Village,  CA  91361 -2628
Applicant Contact Harout Achekian
Correspondent
Med-Device Consulting, Inc.
5804 Rainbow Hill Rd.
Agoura Hills,  CA  91301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/27/2023
Decision Date 06/23/2023
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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