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FDA 510(k)

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR

K-Number: K964743 · 1997-02-03

ApplicantStorz Instrument Co.
Decision Date1997-02-03
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR 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 1997-02-03 under 510(k) number K964743. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ E8010 ERGOTEC/PREMIERE ADAPTOR?

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Storz Instrument Co.. The 510(k) number is K964743.

When did STORZ E8010 ERGOTEC/PREMIERE ADAPTOR receive FDA 510(k) clearance?

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964743.

Who is the listed applicant for STORZ E8010 ERGOTEC/PREMIERE ADAPTOR?

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 E8010 ERGOTEC/PREMIERE ADAPTOR?

The FDA product code for STORZ E8010 ERGOTEC/PREMIERE ADAPTOR is HQE.

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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 NEEDLESK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHK960061STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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