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FDA 510(k)

MEROCEL EPISTACIS KIT

K-Number: K920394 · 1993-03-18

ApplicantMerocel Corp.
Decision Date1993-03-18
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROCEL EPISTACIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K920394. 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 MEROCEL EPISTACIS KIT?

MEROCEL EPISTACIS KIT is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Merocel Corp.. The 510(k) number is K920394.

When did MEROCEL EPISTACIS KIT receive FDA 510(k) clearance?

MEROCEL EPISTACIS KIT received FDA 510(k) clearance on 1993-03-18, under 510(k) number K920394.

Who is the listed applicant for MEROCEL EPISTACIS KIT?

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 MEROCEL EPISTACIS KIT?

The FDA product code for MEROCEL EPISTACIS KIT is EMX.

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Other records listing Merocel Corp. 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.

K954919MEROCEL SOFT WOUND DRESSINGK953072MEROCEL VAGINAL PACKK953013MEROCEL REINFORCED SILICONE SHEETSK943718EPISTAT-II NASAL CATHETERK940572MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)K935658MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT

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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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