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FDA 510(k)

EPISTAT-II NASAL CATHETER

K-Number: K943718 · 1994-09-16

ApplicantMerocel Corp.
Decision Date1994-09-16
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPISTAT-II NASAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K943718. 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 EPISTAT-II NASAL CATHETER?

EPISTAT-II NASAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Merocel Corp.. The 510(k) number is K943718.

When did EPISTAT-II NASAL CATHETER receive FDA 510(k) clearance?

EPISTAT-II NASAL CATHETER received FDA 510(k) clearance on 1994-09-16, under 510(k) number K943718.

Who is the listed applicant for EPISTAT-II NASAL CATHETER?

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

What is the FDA product code for EPISTAT-II NASAL CATHETER?

The FDA product code for EPISTAT-II NASAL CATHETER is EMX.

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Other records listing Merocel Corp. as applicant

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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, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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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