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FDA 510(k)

Repagyn vaginal suppositories

K-Number: K153372 · 2016-06-30

ApplicantFarma-Derma S.R.L.
Decision Date2016-06-30
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Repagyn vaginal suppositories is the device name listed in this FDA 510(k) record. The listed applicant is Farma-Derma S.R.L.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153372. 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 Repagyn vaginal suppositories?

Repagyn vaginal suppositories is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Farma-Derma S.R.L.. The 510(k) number is K153372.

When did Repagyn vaginal suppositories receive FDA 510(k) clearance?

Repagyn vaginal suppositories received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153372.

Who is the listed applicant for Repagyn vaginal suppositories?

The FDA 510(k) record lists Farma-Derma S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Repagyn vaginal suppositories?

The FDA product code for Repagyn vaginal suppositories is NUC.

Other records listing Farma-Derma S.R.L. 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.

K213220Revaree Plus Vaginal 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.

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.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

View on FDA Database →

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

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