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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 K210095
Device Name Playboy Premium Silicone Lubricant
Applicant
Thai Nippon Rubber Industry Public Company Limited
789/139 Pinthong Industrial Estate Nongkham
Sriracha,  TH 20230
Applicant Contact Ryosuke Takamiya
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/14/2021
Decision Date 11/23/2021
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
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