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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 K191654
Device Name SILICONE Personal Lubricant
Bath Concept Cosmetics (Dongguan) Co., Ltd
No.2, Dushang Industrial Zone, DaFen, WanJiang District
Dongguan,  CN 523052
Applicant Contact Jack Yin
RGLM Consulting LLC
3302 171 St Pl SE
Bathell,  WA  98012
Correspondent Contact Wei Zhang
Regulation Number884.5300
Classification Product Code
Date Received06/20/2019
Decision Date 04/14/2020
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