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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 K201922
Device Name Trophikos Vaginal Moisturizer
Applicant
Trophikos, LLC
1212 Collier Rd NW
Atlanta,  GA  30318
Applicant Contact Terri Jackson Wade
Correspondent
Trophikos, LLC c/o ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/10/2020
Decision Date 01/14/2021
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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