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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 K150147
Device Name Lubrigyn cream
Applicant
Uniderm Farmaceutici Srl
Viale Enrico Ortolani 211
Roma,  IT 00125
Applicant Contact Giorgio Chiozza
Correspondent
Isemed S.R.L.
Via A. Altobelli Bonetti 3/A
Imola,  IT 40026
Correspondent Contact Maurizio Pantaleoni
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/22/2015
Decision Date 02/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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