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FDA 510(k)

TAUTONA INJECTOR DEVICE

K-Number: K131963 · 2013-10-22

ApplicantTautona Group, LLC
Decision Date2013-10-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TAUTONA INJECTOR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tautona Group, LLC. It received FDA 510(k) clearance on 2013-10-22 under 510(k) number K131963. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAUTONA INJECTOR DEVICE?

TAUTONA INJECTOR DEVICE is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Tautona Group, LLC. The 510(k) number is K131963.

When did TAUTONA INJECTOR DEVICE receive FDA 510(k) clearance?

TAUTONA INJECTOR DEVICE received FDA 510(k) clearance on 2013-10-22, under 510(k) number K131963.

Who is the listed applicant for TAUTONA INJECTOR DEVICE?

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

What is the FDA product code for TAUTONA INJECTOR DEVICE?

The FDA product code for TAUTONA INJECTOR DEVICE is FMF.

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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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