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FDA 510(k)

ONEUSE- PLUS MICROKERATOME

K-Number: K040297 · 2004-03-31

ApplicantMoria SA
Decision Date2004-03-31
Product CodeHMY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ONEUSE- PLUS MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2004-03-31 under 510(k) number K040297. 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 ONEUSE- PLUS MICROKERATOME?

ONEUSE- PLUS MICROKERATOME is a medical device that received FDA 510(k) clearance on 2004-03-31. The listed applicant is Moria SA. The 510(k) number is K040297.

When did ONEUSE- PLUS MICROKERATOME receive FDA 510(k) clearance?

ONEUSE- PLUS MICROKERATOME received FDA 510(k) clearance on 2004-03-31, under 510(k) number K040297.

Who is the listed applicant for ONEUSE- PLUS MICROKERATOME?

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 ONEUSE- PLUS MICROKERATOME?

The FDA product code for ONEUSE- PLUS MICROKERATOME is HMY.

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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 MICROKERATOMEK022560M2 SINGLE USE MICROKERTOME

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.

K023092BD K-4000 MICROKERATOME SYSTEMBecton, Dickinson & COK022637BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEBecton, Dickinson & COK022560M2 SINGLE USE MICROKERTOMEMoria SAK003594CARRIAZO 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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