HyaloGYN Vaginal Moisturizing Suppositories

Lubricant, Personal

Fidia Farmaceutici S.p.A

The following data is part of a premarket notification filed by Fidia Farmaceutici S.p.a with the FDA for Hyalogyn Vaginal Moisturizing Suppositories.

Pre-market Notification Details

Device IDK191052
510k NumberK191052
Device Name:HyaloGYN Vaginal Moisturizing Suppositories
ClassificationLubricant, Personal
Applicant Fidia Farmaceutici S.p.A Via Ponte Della Fabbrica 3/A Abano Terme,  IT 35031
ContactGiuseppina Lo Castro
CorrespondentVivian Kelly
Fidia Pharma USA, Inc. 100 Campus Drive Florham Park,  NJ  07932
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-19
Decision Date2020-01-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M713100004050 K191052 000
M713100004040 K191052 000
00368093000049 K191052 000
00368093000032 K191052 000

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