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FDA 510(k)

TRACTUS TISSUEMAPPER REVIEWER APPLICATION

K-Number: K123901 · 2013-01-29

ApplicantTractus Corporation
Decision Date2013-01-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRACTUS TISSUEMAPPER REVIEWER APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Tractus Corporation. It received FDA 510(k) clearance on 2013-01-29 under 510(k) number K123901. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACTUS TISSUEMAPPER REVIEWER APPLICATION?

TRACTUS TISSUEMAPPER REVIEWER APPLICATION is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Tractus Corporation. The 510(k) number is K123901.

When did TRACTUS TISSUEMAPPER REVIEWER APPLICATION receive FDA 510(k) clearance?

TRACTUS TISSUEMAPPER REVIEWER APPLICATION received FDA 510(k) clearance on 2013-01-29, under 510(k) number K123901.

Who is the listed applicant for TRACTUS TISSUEMAPPER REVIEWER APPLICATION?

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

What is the FDA product code for TRACTUS TISSUEMAPPER REVIEWER APPLICATION?

The FDA product code for TRACTUS TISSUEMAPPER REVIEWER APPLICATION is LLZ.

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Other records listing Tractus Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131489TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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