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FDA 510(k)

MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT

K-Number: K935658 · 1994-03-04

ApplicantMerocel Corp.
Decision Date1994-03-04
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1994-03-04 under 510(k) number K935658. 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(R) TURBINATE GLOVE AND SEPTAL SPLINT?

MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT is a medical device that received FDA 510(k) clearance on 1994-03-04. The listed applicant is Merocel Corp.. The 510(k) number is K935658.

When did MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT receive FDA 510(k) clearance?

MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT received FDA 510(k) clearance on 1994-03-04, under 510(k) number K935658.

Who is the listed applicant for MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT?

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(R) TURBINATE GLOVE AND SEPTAL SPLINT?

The FDA product code for MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT 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)K933152MEROCEL MEROSPLINT

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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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