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FDA 510(k)

MAGIC EAR, ELAIN

K-Number: K942107 · 1995-02-08

ApplicantNovaplex, Inc.
Decision Date1995-02-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MAGIC EAR, ELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Novaplex, Inc.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K942107. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC EAR, ELAIN?

MAGIC EAR, ELAIN is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Novaplex, Inc.. The 510(k) number is K942107.

When did MAGIC EAR, ELAIN receive FDA 510(k) clearance?

MAGIC EAR, ELAIN received FDA 510(k) clearance on 1995-02-08, under 510(k) number K942107.

Who is the listed applicant for MAGIC EAR, ELAIN?

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

What is the FDA product code for MAGIC EAR, ELAIN?

The FDA product code for MAGIC EAR, ELAIN is ESD.

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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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