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FDA 510(k)

KERATOME BLADE 200200 & 600600

K-Number: K020482 · 2002-12-16

ApplicantMicro Specialties, Inc.
Decision Date2002-12-16
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERATOME BLADE 200200 & 600600 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 2002-12-16 under 510(k) number K020482. 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 KERATOME BLADE 200200 & 600600?

KERATOME BLADE 200200 & 600600 is a medical device that received FDA 510(k) clearance on 2002-12-16. The listed applicant is Micro Specialties, Inc.. The 510(k) number is K020482.

When did KERATOME BLADE 200200 & 600600 receive FDA 510(k) clearance?

KERATOME BLADE 200200 & 600600 received FDA 510(k) clearance on 2002-12-16, under 510(k) number K020482.

Who is the listed applicant for KERATOME BLADE 200200 & 600600?

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 KERATOME BLADE 200200 & 600600?

The FDA product code for KERATOME BLADE 200200 & 600600 is HNO.

Related Clinical Trials

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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.

K033457M2 COMPATIBLE MICROKERATOME BLADEK980508KERATOME 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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