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FDA 510(k)

EPIFLO-28

K-Number: K190742 · 2019-12-13

ApplicantNeogenix, LLC Dba Ogenix
Decision Date2019-12-13
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPIFLO-28 is a medical device manufactured by Neogenix, LLC Dba Ogenix. It received FDA 510(k) clearance on 2019-12-13 under approval number K190742. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIFLO-28?

EPIFLO-28 is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Neogenix, LLC Dba Ogenix. The 510(k) number is K190742.

When was EPIFLO-28 approved by the FDA?

EPIFLO-28 received FDA 510(k) clearance on 2019-12-13, under approval number K190742.

What company makes EPIFLO-28?

EPIFLO-28 is manufactured by Neogenix, LLC Dba Ogenix.

What is the FDA product code for EPIFLO-28?

The FDA product code for EPIFLO-28 is KPJ.

Related Devices (Code: KPJ)

K212121VHT-200 Wound Treatment SystemVaporox, Inc. K250188Wound Treatment System (VHT-200)Vaporox, Inc.

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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