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FDA 510(k)

GOODE MAGNETIC NASAL SPLINT

K-Number: K810738 · 1981-03-31

ApplicantXomed, Inc.
Decision Date1981-03-31
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GOODE MAGNETIC NASAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810738. The device is classified under product code EPP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOODE MAGNETIC NASAL SPLINT?

GOODE MAGNETIC NASAL SPLINT is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Xomed, Inc.. The 510(k) number is K810738.

When did GOODE MAGNETIC NASAL SPLINT receive FDA 510(k) clearance?

GOODE MAGNETIC NASAL SPLINT received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810738.

Who is the listed applicant for GOODE MAGNETIC NASAL SPLINT?

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

What is the FDA product code for GOODE MAGNETIC NASAL SPLINT?

The FDA product code for GOODE MAGNETIC NASAL SPLINT is EPP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Xomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EPP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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