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FDA 510(k)

EAR AND NOSE SPECULA

K-Number: K791123 · 1979-07-10

ApplicantXomed, Inc.
Decision Date1979-07-10
Product CodeEPY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EAR AND NOSE SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1979-07-10 under 510(k) number K791123. The device is classified under product code EPY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR AND NOSE SPECULA?

EAR AND NOSE SPECULA is a medical device that received FDA 510(k) clearance on 1979-07-10. The listed applicant is Xomed, Inc.. The 510(k) number is K791123.

When did EAR AND NOSE SPECULA receive FDA 510(k) clearance?

EAR AND NOSE SPECULA received FDA 510(k) clearance on 1979-07-10, under 510(k) number K791123.

Who is the listed applicant for EAR AND NOSE SPECULA?

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 EAR AND NOSE SPECULA?

The FDA product code for EAR AND NOSE SPECULA is EPY.

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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: EPY)

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.

K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.K925754ECONOMRudolf Riester GmbH & Co. KGK853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.K822370UNIVERSAL SPECULUM HOLDERTreace Medical, Inc.K822373EAR SURGERY SPECULUMTreace Medical, Inc.

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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