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FDA 510(k)

FUJI ORTHO LC

K-Number: K950556 · 1995-03-08

ApplicantGC America, Inc.
Decision Date1995-03-08
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUJI ORTHO LC is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1995-03-08 under 510(k) number K950556. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI ORTHO LC?

FUJI ORTHO LC is a medical device that received FDA 510(k) clearance on 1995-03-08. The listed applicant is GC America, Inc.. The 510(k) number is K950556.

When did FUJI ORTHO LC receive FDA 510(k) clearance?

FUJI ORTHO LC received FDA 510(k) clearance on 1995-03-08, under 510(k) number K950556.

Who is the listed applicant for FUJI ORTHO LC?

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

What is the FDA product code for FUJI ORTHO LC?

The FDA product code for FUJI ORTHO LC is DYH.

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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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