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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 K180828
Device Name Natureplex Warm Touch Warming Jelly
Applicant
Natureplex, LLC
11085 Airport Rd.
Olive Branch,  MS  38654
Applicant Contact Pamela Hopkins
Correspondent
Natureplex, LLC
11085 Airport Rd.
Olive Branch,  MS  38654
Correspondent Contact Pamela Hopkins
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/30/2018
Decision Date 12/20/2018
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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