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FDA 510(k)

FLAPMAKER DISPOSABLE MICROKERATOME

K-Number: K981155 · 1998-08-14

ApplicantHawken Industries
Decision Date1998-08-14
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FLAPMAKER DISPOSABLE MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Hawken Industries. It received FDA 510(k) clearance on 1998-08-14 under 510(k) number K981155. 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 FLAPMAKER DISPOSABLE MICROKERATOME?

FLAPMAKER DISPOSABLE MICROKERATOME is a medical device that received FDA 510(k) clearance on 1998-08-14. The listed applicant is Hawken Industries. The 510(k) number is K981155.

When did FLAPMAKER DISPOSABLE MICROKERATOME receive FDA 510(k) clearance?

FLAPMAKER DISPOSABLE MICROKERATOME received FDA 510(k) clearance on 1998-08-14, under 510(k) number K981155.

Who is the listed applicant for FLAPMAKER DISPOSABLE MICROKERATOME?

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

What is the FDA product code for FLAPMAKER DISPOSABLE MICROKERATOME?

The FDA product code for FLAPMAKER DISPOSABLE MICROKERATOME 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 Hawken Industries 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.

K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

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

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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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