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FDA 510(k)

PLANMECA SOVEREIGN

K-Number: K081699 · 2008-08-29

ApplicantPlanmeca USA, Inc.
Decision Date2008-08-29
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLANMECA SOVEREIGN is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca USA, Inc.. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K081699. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMECA SOVEREIGN?

PLANMECA SOVEREIGN is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K081699.

When did PLANMECA SOVEREIGN receive FDA 510(k) clearance?

PLANMECA SOVEREIGN received FDA 510(k) clearance on 2008-08-29, under 510(k) number K081699.

Who is the listed applicant for PLANMECA SOVEREIGN?

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

What is the FDA product code for PLANMECA SOVEREIGN?

The FDA product code for PLANMECA SOVEREIGN is EIA.

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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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