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FDA 510(k)

HYALO GYN

K-Number: K094039 · 2010-05-07

ApplicantFidia Farmaceutici S.P.A.
Decision Date2010-05-07
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYALO GYN is the device name listed in this FDA 510(k) record. The listed applicant is Fidia Farmaceutici S.P.A.. It received FDA 510(k) clearance on 2010-05-07 under 510(k) number K094039. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYALO GYN?

HYALO GYN is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is Fidia Farmaceutici S.P.A.. The 510(k) number is K094039.

When did HYALO GYN receive FDA 510(k) clearance?

HYALO GYN received FDA 510(k) clearance on 2010-05-07, under 510(k) number K094039.

Who is the listed applicant for HYALO GYN?

The FDA 510(k) record lists Fidia Farmaceutici S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYALO GYN?

The FDA product code for HYALO GYN is NUC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Fidia Farmaceutici S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191052HyaloGYN Vaginal Moisturizing Suppositories

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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