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FDA 510(k)

HYDROFERA BACTERISTATIC NASAL DRESSING

K-Number: K983276 · 1999-09-14

ApplicantHydrofera, LLC
Decision Date1999-09-14
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HYDROFERA BACTERISTATIC NASAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 1999-09-14 under 510(k) number K983276. 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 HYDROFERA BACTERISTATIC NASAL DRESSING?

HYDROFERA BACTERISTATIC NASAL DRESSING is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Hydrofera, LLC. The 510(k) number is K983276.

When did HYDROFERA BACTERISTATIC NASAL DRESSING receive FDA 510(k) clearance?

HYDROFERA BACTERISTATIC NASAL DRESSING received FDA 510(k) clearance on 1999-09-14, under 510(k) number K983276.

Who is the listed applicant for HYDROFERA BACTERISTATIC NASAL DRESSING?

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

What is the FDA product code for HYDROFERA BACTERISTATIC NASAL DRESSING?

The FDA product code for HYDROFERA BACTERISTATIC NASAL DRESSING 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hydrofera, LLC 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.

K190268Hydrofera Blue READY - BorderK023138HYDROFERA BACTERIOSTATIC WOUND DRESSINGK013462HYDROFERA BACTERIOSTATIC WOUND DRESSINGK974313HYDROFERA SURGICAL SPEARK974316HYDROFERA FEMORAL WICK

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.K982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.K984069ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.

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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