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FDA 510(k)

INTERMEZZO PLUS FIXTURE

K-Number: K053354 · 2006-04-13

ApplicantMegagen Co., Ltd.
Decision Date2006-04-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTERMEZZO PLUS FIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Co., Ltd.. It received FDA 510(k) clearance on 2006-04-13 under 510(k) number K053354. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMEZZO PLUS FIXTURE?

INTERMEZZO PLUS FIXTURE is a medical device that received FDA 510(k) clearance on 2006-04-13. The listed applicant is Megagen Co., Ltd.. The 510(k) number is K053354.

When did INTERMEZZO PLUS FIXTURE receive FDA 510(k) clearance?

INTERMEZZO PLUS FIXTURE received FDA 510(k) clearance on 2006-04-13, under 510(k) number K053354.

Who is the listed applicant for INTERMEZZO PLUS FIXTURE?

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

What is the FDA product code for INTERMEZZO PLUS FIXTURE?

The FDA product code for INTERMEZZO PLUS FIXTURE is DZE.

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Other records listing Megagen Co., Ltd. as applicant

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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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