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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 K094039
FOIA Releasable 510(k) K094039
Device Name HYALO GYN
Applicant
Fidia Farmaceutici S.P.A.
Via Ponte Della Fabbrica 3/A
Abano Terme,  IT 35031
Applicant Contact GIUSI LOCASTRO
Correspondent
Fidia Farmaceutici S.P.A.
Via Ponte Della Fabbrica 3/A
Abano Terme,  IT 35031
Correspondent Contact GIUSI LOCASTRO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/30/2009
Decision Date 05/07/2010
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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