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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 K200098
Device Name VagiVital Aktivgel
Applicant
Peptonic Medical AB
Gustavslundsvagen 143
Bromma,  SE 16751
Applicant Contact Dan Markusson
Correspondent
J&D Campbell Associates, Inc.
164 Hammock Ave.
Pawleys Island,  SC  29585
Correspondent Contact Jane Campbell
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/16/2020
Decision Date 11/10/2020
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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