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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 the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2019-04-30 under 510(k) 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. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K190305.

When did Additive Cap receive FDA 510(k) clearance?

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

Who is the listed applicant for Additive Cap?

The FDA 510(k) record lists International Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Additive Cap?

The FDA product code for Additive Cap is KPE.

Other records listing International Medical Industries, Inc. as applicant

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Related Devices (Code: 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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