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FDA 510(k)

FITE FIXATION TOY FOR OCULAR EXAM

K-Number: K801381 · 1980-07-28

ApplicantFite Engineering Corp.
Decision Date1980-07-28
Product CodeHPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FITE FIXATION TOY FOR OCULAR EXAM is the device name listed in this FDA 510(k) record. The listed applicant is Fite Engineering Corp.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801381. The device is classified under product code HPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITE FIXATION TOY FOR OCULAR EXAM?

FITE FIXATION TOY FOR OCULAR EXAM is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Fite Engineering Corp.. The 510(k) number is K801381.

When did FITE FIXATION TOY FOR OCULAR EXAM receive FDA 510(k) clearance?

FITE FIXATION TOY FOR OCULAR EXAM received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801381.

Who is the listed applicant for FITE FIXATION TOY FOR OCULAR EXAM?

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

What is the FDA product code for FITE FIXATION TOY FOR OCULAR EXAM?

The FDA product code for FITE FIXATION TOY FOR OCULAR EXAM is HPL.

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Related Devices (Code: HPL)

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.

K931731STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERYStorz Instrument Co.K933739360 DEGREE FIXATION LIGHTVaritronicsK873914ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)Richmond Products, Inc.K854383KERATOLUXCarl Zeiss, Inc.K800112AMBLYOPIA TRAINERLife-Tech Instruments, Inc.K781313VISION-STIMULATOR, CAMClement Clarke, 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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