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FDA 510(k)

Prometheus ChitoGauze XR PRO

K-Number: K153582 · 2016-05-25

ApplicantHem Con Medical Technologies, Inc.
Decision Date2016-05-25
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Prometheus ChitoGauze XR PRO is a medical device manufactured by Hem Con Medical Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-25 under approval number K153582. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prometheus ChitoGauze XR PRO?

Prometheus ChitoGauze XR PRO is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Hem Con Medical Technologies, Inc.. The 510(k) number is K153582.

When was Prometheus ChitoGauze XR PRO approved by the FDA?

Prometheus ChitoGauze XR PRO received FDA 510(k) clearance on 2016-05-25, under approval number K153582.

What company makes Prometheus ChitoGauze XR PRO?

Prometheus ChitoGauze XR PRO is manufactured by Hem Con Medical Technologies, Inc..

What is the FDA product code for Prometheus ChitoGauze XR PRO?

The FDA product code for Prometheus ChitoGauze XR PRO is QSY.

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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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