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FDA 510(k)

ENDOSCOPIC TRANSLUMINATOR

K-Number: K915854 · 1992-03-18

ApplicantO.R. Concepts, Inc.
Decision Date1992-03-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC TRANSLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Concepts, Inc.. It received FDA 510(k) clearance on 1992-03-18 under 510(k) number K915854. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC TRANSLUMINATOR?

ENDOSCOPIC TRANSLUMINATOR is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K915854.

When did ENDOSCOPIC TRANSLUMINATOR receive FDA 510(k) clearance?

ENDOSCOPIC TRANSLUMINATOR received FDA 510(k) clearance on 1992-03-18, under 510(k) number K915854.

Who is the listed applicant for ENDOSCOPIC TRANSLUMINATOR?

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

What is the FDA product code for ENDOSCOPIC TRANSLUMINATOR?

The FDA product code for ENDOSCOPIC TRANSLUMINATOR is GCJ.

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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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