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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 K150883
FOIA Releasable 510(k) K150883
Device Name HyaloGYN Vaginal Hydrating Gel
Applicant
FIDIA FARMACEUTICI SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME,  IT 35031
Applicant Contact Dr. Giuseppina Lo Castro
Correspondent
Fidia Pharma USA Inc
Morris Corporate Center 1, Building C, 300 Interpace Parkway
Parsippany,  NJ  07054
Correspondent Contact Vivian Kelly
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/02/2015
Decision Date 09/01/2015
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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