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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 K220273
Device Name Onetouch Non-paraben Lubricant Gel
Applicant
Thai Nippon Rubber Industry Public Company Limited.
789/139 Pinthong Industrial Estate Nongkham
Sriracha,  TH 20230
Applicant Contact Tossaporn Nilkhamhang
Correspondent
Thai Nippon Rubber Industry Public Company Limited.
789/139 Pinthong Industrial Estate Nongkham
Sriracha,  TH 20230
Correspondent Contact Tossaporn Nilkhamhang
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/31/2022
Decision Date 10/21/2022
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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