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FDA 510(k)

M2 SINGLE USE MICROKERTOME

K-Number: K022560 · 2002-09-27

ApplicantMoria SA
Decision Date2002-09-27
Product CodeHMY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

M2 SINGLE USE MICROKERTOME is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2002-09-27 under 510(k) number K022560. The device is classified under product code HMY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M2 SINGLE USE MICROKERTOME?

M2 SINGLE USE MICROKERTOME is a medical device that received FDA 510(k) clearance on 2002-09-27. The listed applicant is Moria SA. The 510(k) number is K022560.

When did M2 SINGLE USE MICROKERTOME receive FDA 510(k) clearance?

M2 SINGLE USE MICROKERTOME received FDA 510(k) clearance on 2002-09-27, under 510(k) number K022560.

Who is the listed applicant for M2 SINGLE USE MICROKERTOME?

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

What is the FDA product code for M2 SINGLE USE MICROKERTOME?

The FDA product code for M2 SINGLE USE MICROKERTOME is HMY.

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.

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Other records listing Moria SA 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.

K172994EPI K ConsoleK043183EPI-KK032836M3 MICROKERATOMEK040297ONEUSE- PLUS MICROKERATOME

Related Devices (Code: HMY)

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.

K040297ONEUSE- PLUS MICROKERATOMEMoria SAK023092BD K-4000 MICROKERATOME SYSTEMBecton, Dickinson & COK022637BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEBecton, Dickinson & COK003594CARRIAZO BARRAQUER SINGLE USE MICROKERATOMEMoria, Inc.K002191CARRIAZO BARRAQUER II MICROKERATOMEMoria, Inc.K992687MILLENIUM MICROKERATOME, MODEL IMD-001Industrial & Medical Design, Inc.

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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