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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 K132772
Device Name LUBRIGYN CREAM
Applicant
UNIDERM FARMACEUTICI SRL
VIA A. ALTOBELLI BONETTI 3A
IMOLA, BO,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
UNIDERM FARMACEUTICI SRL
VIA A. ALTOBELLI BONETTI 3A
IMOLA, BO,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/05/2013
Decision Date 08/22/2014
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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