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FDA 510(k)

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)

K-Number: K072231 · 2007-12-26

ApplicantEsm Technologies, LLC
Decision Date2007-12-26
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) is the device name listed in this FDA 510(k) record. The listed applicant is Esm Technologies, LLC. It received FDA 510(k) clearance on 2007-12-26 under 510(k) number K072231. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)?

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) is a medical device that received FDA 510(k) clearance on 2007-12-26. The listed applicant is Esm Technologies, LLC. The 510(k) number is K072231.

When did THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) receive FDA 510(k) clearance?

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) received FDA 510(k) clearance on 2007-12-26, under 510(k) number K072231.

Who is the listed applicant for THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)?

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

What is the FDA product code for THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)?

The FDA product code for THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) is KWQ.

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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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