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FDA 510(k)

EYE SURGERY INSTRUMENT

K-Number: K840101 · 1984-03-16

ApplicantTruline Instruments, Inc.
Decision Date1984-03-16
Product CodeHOB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE SURGERY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Truline Instruments, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840101. The device is classified under product code HOB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE SURGERY INSTRUMENT?

EYE SURGERY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Truline Instruments, Inc.. The 510(k) number is K840101.

When did EYE SURGERY INSTRUMENT receive FDA 510(k) clearance?

EYE SURGERY INSTRUMENT received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840101.

Who is the listed applicant for EYE SURGERY INSTRUMENT?

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

What is the FDA product code for EYE SURGERY INSTRUMENT?

The FDA product code for EYE SURGERY INSTRUMENT is HOB.

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Related Devices (Code: HOB)

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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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