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FDA 510(k)

Additive Cap

K-Number: K190305 · 2019-04-30

ApplicantInternational Medical Industries, Inc.
Decision Date2019-04-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Additive Cap is a medical device manufactured by International Medical Industries, Inc.. It received FDA 510(k) clearance on 2019-04-30 under approval number K190305. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Cap?

Additive Cap is a medical device that received FDA 510(k) clearance on 2019-04-30. It is manufactured by International Medical Industries, Inc.. The 510(k) number is K190305.

When was Additive Cap approved by the FDA?

Additive Cap received FDA 510(k) clearance on 2019-04-30, under approval number K190305.

What company makes Additive Cap?

Additive Cap is manufactured by International Medical Industries, Inc..

What is the FDA product code for Additive Cap?

The FDA product code for Additive Cap is KPE.

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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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