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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 K143349
Device Name Gynomunal
Applicant
Polichem S.A
Via Senago 42d
Lugano-Pazzallo,  CH 6912
Applicant Contact Daria Mari
Correspondent
RQMIS, Inc.
29 Water St.
Suite 305
Newburyport,  MA  01950
Correspondent Contact Barry E Sands
Regulation Number884.5300
Classification Product Code
NUC  
Date Received11/24/2014
Decision Date 09/16/2015
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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