FDA 510(k)

Repagyn vaginal suppositories

K-Number: K153372 · 2016-06-30

Decision Date2016-06-30

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Repagyn vaginal suppositories is a medical device manufactured by Farma-Derma S.R.L.. It received FDA 510(k) clearance on 2016-06-30 under approval 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. It is manufactured by Farma-Derma S.R.L.. The 510(k) number is K153372.

When was Repagyn vaginal suppositories approved by the FDA?

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

What company makes Repagyn vaginal suppositories?

Repagyn vaginal suppositories is manufactured by Farma-Derma S.R.L..

What is the FDA product code for Repagyn vaginal suppositories?

The FDA product code for Repagyn vaginal suppositories is NUC.

Other Devices by Farma-Derma S.R.L.

K213220Revaree Plus Vaginal Suppositories

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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.