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FDA 510(k)

STORZ DRAEGER ROTOR KERATOME

K-Number: K904845 · 1991-01-22

ApplicantStorz Instrument Co.
Decision Date1991-01-22
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STORZ DRAEGER ROTOR KERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Storz Instrument Co.. It received FDA 510(k) clearance on 1991-01-22 under 510(k) number K904845. 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 STORZ DRAEGER ROTOR KERATOME?

STORZ DRAEGER ROTOR KERATOME is a medical device that received FDA 510(k) clearance on 1991-01-22. The listed applicant is Storz Instrument Co.. The 510(k) number is K904845.

When did STORZ DRAEGER ROTOR KERATOME receive FDA 510(k) clearance?

STORZ DRAEGER ROTOR KERATOME received FDA 510(k) clearance on 1991-01-22, under 510(k) number K904845.

Who is the listed applicant for STORZ DRAEGER ROTOR KERATOME?

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

What is the FDA product code for STORZ DRAEGER ROTOR KERATOME?

The FDA product code for STORZ DRAEGER ROTOR KERATOME is HNO.

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Other records listing Storz Instrument Co. 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.

K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKK980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMK972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMK971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESK964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

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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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