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FDA 510(k)

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME

K-Number: K980675 · 1998-12-22

ApplicantSummit Technology, Inc.
Decision Date1998-12-22
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Summit Technology, Inc.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K980675. 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 SUMMIT KRUMEICH-BARRAQUER MICROKERATOME?

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Summit Technology, Inc.. The 510(k) number is K980675.

When did SUMMIT KRUMEICH-BARRAQUER MICROKERATOME receive FDA 510(k) clearance?

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME received FDA 510(k) clearance on 1998-12-22, under 510(k) number K980675.

Who is the listed applicant for SUMMIT KRUMEICH-BARRAQUER MICROKERATOME?

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

What is the FDA product code for SUMMIT KRUMEICH-BARRAQUER MICROKERATOME?

The FDA product code for SUMMIT KRUMEICH-BARRAQUER MICROKERATOME is HNO.

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Other records listing Summit Technology, 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.

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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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