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FDA 510(k)

ENTAXIS NASAL PACKING

K-Number: K984069 · 1999-01-25

ApplicantLes Laboratorires Brothier, S.A.
Decision Date1999-01-25
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTAXIS NASAL PACKING is the device name listed in this FDA 510(k) record. The listed applicant is Les Laboratorires Brothier, S.A.. It received FDA 510(k) clearance on 1999-01-25 under 510(k) number K984069. 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 ENTAXIS NASAL PACKING?

ENTAXIS NASAL PACKING is a medical device that received FDA 510(k) clearance on 1999-01-25. The listed applicant is Les Laboratorires Brothier, S.A.. The 510(k) number is K984069.

When did ENTAXIS NASAL PACKING receive FDA 510(k) clearance?

ENTAXIS NASAL PACKING received FDA 510(k) clearance on 1999-01-25, under 510(k) number K984069.

Who is the listed applicant for ENTAXIS NASAL PACKING?

The FDA 510(k) record lists Les Laboratorires Brothier, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTAXIS NASAL PACKING?

The FDA product code for ENTAXIS NASAL PACKING is EMX.

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.

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Other records listing Les Laboratorires Brothier, S.A. 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.

K041446NASALCEASEK922540WOUND DRESSINGK905314ALGODERM ALGINATE WOUND DRESSINGK893123ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES

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, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.

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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