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FDA 510(k)

CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE

K-Number: K861825 · 1986-06-09

ApplicantStorz Instrument Co.
Decision Date1986-06-09
Product CodeHRH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE 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 1986-06-09 under 510(k) number K861825. The device is classified under product code HRH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE?

CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Storz Instrument Co.. The 510(k) number is K861825.

When did CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE receive FDA 510(k) clearance?

CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861825.

Who is the listed applicant for CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE?

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 CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE?

The FDA product code for CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE is HRH.

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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: HRH)

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.

K022843GAYHEART CORNEAL EXCISION DEVICEStephens InstrumentsK931792ARTHROSCOPEIntramed Laboratories, Inc.K873918HEAD & CHIN RESTSRichmond Products, Inc.K864520BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.K862524DEKNATEL (R) TREPHINEDeknatel, Inc.K860648BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIAPrecision Instruments, Inc.

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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