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FDA 510(k)

M2 COMPATIBLE MICROKERATOME BLADE

K-Number: K033457 · 2004-05-25

ApplicantMicro Specialties, Inc.
Decision Date2004-05-25
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

M2 COMPATIBLE MICROKERATOME BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Micro Specialties, Inc.. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K033457. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M2 COMPATIBLE MICROKERATOME BLADE?

M2 COMPATIBLE MICROKERATOME BLADE is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Micro Specialties, Inc.. The 510(k) number is K033457.

When did M2 COMPATIBLE MICROKERATOME BLADE receive FDA 510(k) clearance?

M2 COMPATIBLE MICROKERATOME BLADE received FDA 510(k) clearance on 2004-05-25, under 510(k) number K033457.

Who is the listed applicant for M2 COMPATIBLE MICROKERATOME BLADE?

The FDA 510(k) record lists Micro Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M2 COMPATIBLE MICROKERATOME BLADE?

The FDA product code for M2 COMPATIBLE MICROKERATOME BLADE is HNO.

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 Micro Specialties, Inc. 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.

K020482KERATOME BLADE 200200 & 600600K980508KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400K980510KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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