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FDA 510(k)

TRIMOTION INJECTOR

K-Number: K102999 · 2011-12-29

ApplicantKaneka Corp.
Decision Date2011-12-29
Product CodeOTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRIMOTION INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Corp.. It received FDA 510(k) clearance on 2011-12-29 under 510(k) number K102999. The device is classified under product code OTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMOTION INJECTOR?

TRIMOTION INJECTOR is a medical device that received FDA 510(k) clearance on 2011-12-29. The listed applicant is Kaneka Corp.. The 510(k) number is K102999.

When did TRIMOTION INJECTOR receive FDA 510(k) clearance?

TRIMOTION INJECTOR received FDA 510(k) clearance on 2011-12-29, under 510(k) number K102999.

Who is the listed applicant for TRIMOTION INJECTOR?

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

What is the FDA product code for TRIMOTION INJECTOR?

The FDA product code for TRIMOTION INJECTOR is OTZ.

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Related Devices (Code: OTZ)

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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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