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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 K234099
Device Name Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
Applicant
Select Labs, LLC
4236 Wilkinson Blvd.
Charlotte,  NC  28208
Applicant Contact Om Singh
Correspondent
Lucida Scientific and Regulatory Consulting, LLC
9667 Norfolk Ave.
Laurel,  MD  20723
Correspondent Contact Om Singh
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/26/2023
Decision Date 06/07/2024
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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