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FDA 510(k)

SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE

K-Number: K904470 · 1990-12-24

ApplicantSummit Technology, Inc.
Decision Date1990-12-24
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE 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 1990-12-24 under 510(k) number K904470. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE?

SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE is a medical device that received FDA 510(k) clearance on 1990-12-24. The listed applicant is Summit Technology, Inc.. The 510(k) number is K904470.

When did SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE receive FDA 510(k) clearance?

SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE received FDA 510(k) clearance on 1990-12-24, under 510(k) number K904470.

Who is the listed applicant for SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE?

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 TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE?

The FDA product code for SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE is EQH.

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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.

K980675SUMMIT KRUMEICH-BARRAQUER MICROKERATOMEK926470LASER AND EMPHASIS SCLEROSTOMY TIPK915651OMNIMED HOLMIUM LASER AND DELIVERY SYSTEMK912522OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER

Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, Inc.

Official Source

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