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FDA 510(k)

MEROGEL NASAL DRESSING AND SINUS STENT

K-Number: K982731 · 1999-02-02

ApplicantXomed, Inc.
Decision Date1999-02-02
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROGEL NASAL DRESSING AND SINUS STENT is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K982731. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROGEL NASAL DRESSING AND SINUS STENT?

MEROGEL NASAL DRESSING AND SINUS STENT is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Xomed, Inc.. The 510(k) number is K982731.

When did MEROGEL NASAL DRESSING AND SINUS STENT receive FDA 510(k) clearance?

MEROGEL NASAL DRESSING AND SINUS STENT received FDA 510(k) clearance on 1999-02-02, under 510(k) number K982731.

Who is the listed applicant for MEROGEL NASAL DRESSING AND SINUS STENT?

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 MEROGEL NASAL DRESSING AND SINUS STENT?

The FDA product code for MEROGEL NASAL DRESSING AND SINUS STENT is EMX.

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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: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK984069ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.

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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