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FDA 510(k)

EMBLETTA GOLD

K-Number: K073682 · 2008-08-08

ApplicantEmbla Systems, Inc.
Decision Date2008-08-08
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMBLETTA GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K073682. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBLETTA GOLD?

EMBLETTA GOLD is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Embla Systems, Inc.. The 510(k) number is K073682.

When did EMBLETTA GOLD receive FDA 510(k) clearance?

EMBLETTA GOLD received FDA 510(k) clearance on 2008-08-08, under 510(k) number K073682.

Who is the listed applicant for EMBLETTA GOLD?

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

What is the FDA product code for EMBLETTA GOLD?

The FDA product code for EMBLETTA GOLD is MNR.

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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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