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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 K254011
Device Name Flow Water-Based Personal Lubricant
Applicant
LBDO Group, Inc.
610 Eastern Pkwy.
Brooklyn,  NY  11225
Applicant Contact Joshua Benjamin
Correspondent
LBDO Group, Inc.
610 Eastern Pkwy.
Brooklyn,  NY  11225
Correspondent Contact Joshua Benjamin
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/15/2025
Decision Date 06/22/2026
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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