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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 STREET
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
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