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FDA 510(k)

KMD-MARK1 TISSUE MARKER

K-Number: K093473 · 2010-07-02

ApplicantKent Medical Devices, Inc.
Decision Date2010-07-02
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KMD-MARK1 TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Kent Medical Devices, Inc.. It received FDA 510(k) clearance on 2010-07-02 under 510(k) number K093473. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMD-MARK1 TISSUE MARKER?

KMD-MARK1 TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is Kent Medical Devices, Inc.. The 510(k) number is K093473.

When did KMD-MARK1 TISSUE MARKER receive FDA 510(k) clearance?

KMD-MARK1 TISSUE MARKER received FDA 510(k) clearance on 2010-07-02, under 510(k) number K093473.

Who is the listed applicant for KMD-MARK1 TISSUE MARKER?

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

What is the FDA product code for KMD-MARK1 TISSUE MARKER?

The FDA product code for KMD-MARK1 TISSUE MARKER is NEU.

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Related Devices (Code: NEU)

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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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