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FDA 510(k)

MEROCEL MEROSPLINT

K-Number: K933152 · 1993-08-17

ApplicantMerocel Corp.
Decision Date1993-08-17
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROCEL MEROSPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1993-08-17 under 510(k) number K933152. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROCEL MEROSPLINT?

MEROCEL MEROSPLINT is a medical device that received FDA 510(k) clearance on 1993-08-17. The listed applicant is Merocel Corp.. The 510(k) number is K933152.

When did MEROCEL MEROSPLINT receive FDA 510(k) clearance?

MEROCEL MEROSPLINT received FDA 510(k) clearance on 1993-08-17, under 510(k) number K933152.

Who is the listed applicant for MEROCEL MEROSPLINT?

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 MEROSPLINT?

The FDA product code for MEROCEL MEROSPLINT is LYA.

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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: LYA)

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.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

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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