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FDA 510(k)

KENSTONE

K-Number: K990139 · 1999-04-29

ApplicantKenda USA
Decision Date1999-04-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KENSTONE is the device name listed in this FDA 510(k) record. The listed applicant is Kenda USA. It received FDA 510(k) clearance on 1999-04-29 under 510(k) number K990139. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENSTONE?

KENSTONE is a medical device that received FDA 510(k) clearance on 1999-04-29. The listed applicant is Kenda USA. The 510(k) number is K990139.

When did KENSTONE receive FDA 510(k) clearance?

KENSTONE received FDA 510(k) clearance on 1999-04-29, under 510(k) number K990139.

Who is the listed applicant for KENSTONE?

The FDA 510(k) record lists Kenda USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENSTONE?

The FDA product code for KENSTONE is IOR.

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Related Devices (Code: IOR)

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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.

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