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FDA 510(k)

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML

K-Number: K121964 · 2013-01-23

ApplicantAugmenix, Inc.
Decision Date2013-01-23
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML is the device name listed in this FDA 510(k) record. The listed applicant is Augmenix, Inc.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K121964. 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 MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML?

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Augmenix, Inc.. The 510(k) number is K121964.

When did MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML receive FDA 510(k) clearance?

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML received FDA 510(k) clearance on 2013-01-23, under 510(k) number K121964.

Who is the listed applicant for MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML?

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

What is the FDA product code for MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML?

The FDA product code for MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML 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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