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FDA 510(k)

TANTHERA-T35

K-Number: K090831 · 2009-05-29

ApplicantTanthera, Inc.
Decision Date2009-05-29
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANTHERA-T35 is the device name listed in this FDA 510(k) record. The listed applicant is Tanthera, Inc.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K090831. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANTHERA-T35?

TANTHERA-T35 is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Tanthera, Inc.. The 510(k) number is K090831.

When did TANTHERA-T35 receive FDA 510(k) clearance?

TANTHERA-T35 received FDA 510(k) clearance on 2009-05-29, under 510(k) number K090831.

Who is the listed applicant for TANTHERA-T35?

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

What is the FDA product code for TANTHERA-T35?

The FDA product code for TANTHERA-T35 is LEJ.

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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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