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FDA 510(k)

TRANSET SYSTEM

K-Number: K060283 · 2006-02-22

ApplicantBonutti Research, Inc.
Decision Date2006-02-22
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANSET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K060283. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSET SYSTEM?

TRANSET SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K060283.

When did TRANSET SYSTEM receive FDA 510(k) clearance?

TRANSET SYSTEM received FDA 510(k) clearance on 2006-02-22, under 510(k) number K060283.

Who is the listed applicant for TRANSET SYSTEM?

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

What is the FDA product code for TRANSET SYSTEM?

The FDA product code for TRANSET SYSTEM is HTY.

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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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