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FDA 510(k)

OPACITRAC

K-Number: K915356 · 1992-02-21

ApplicantOculon Corp.
Decision Date1992-02-21
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPACITRAC is the device name listed in this FDA 510(k) record. The listed applicant is Oculon Corp.. It received FDA 510(k) clearance on 1992-02-21 under 510(k) number K915356. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPACITRAC?

OPACITRAC is a medical device that received FDA 510(k) clearance on 1992-02-21. The listed applicant is Oculon Corp.. The 510(k) number is K915356.

When did OPACITRAC receive FDA 510(k) clearance?

OPACITRAC received FDA 510(k) clearance on 1992-02-21, under 510(k) number K915356.

Who is the listed applicant for OPACITRAC?

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

What is the FDA product code for OPACITRAC?

The FDA product code for OPACITRAC is HJO.

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Related Devices (Code: HJO)

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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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