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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 SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME, PADUA (PD),  IT 35031
Applicant Contact GIUSI LOCASTRO
Correspondent
FIDIA FARMACEUTICI SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME, PADUA (PD),  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
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