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FDA 510(k)

XOMED MICRO-IRRIGATOR

K-Number: K813475 · 1982-02-04

ApplicantXomed, Inc.
Decision Date1982-02-04
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

XOMED MICRO-IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813475. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED MICRO-IRRIGATOR?

XOMED MICRO-IRRIGATOR is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Xomed, Inc.. The 510(k) number is K813475.

When did XOMED MICRO-IRRIGATOR receive FDA 510(k) clearance?

XOMED MICRO-IRRIGATOR received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813475.

Who is the listed applicant for XOMED MICRO-IRRIGATOR?

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 XOMED MICRO-IRRIGATOR?

The FDA product code for XOMED MICRO-IRRIGATOR is FQH.

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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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: FQH)

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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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