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FDA 510(k)

FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)

K-Number: K884631 · 1989-03-22

ApplicantXomed, Inc.
Decision Date1989-03-22
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K884631. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)?

FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Xomed, Inc.. The 510(k) number is K884631.

When did FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) receive FDA 510(k) clearance?

FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) received FDA 510(k) clearance on 1989-03-22, under 510(k) number K884631.

Who is the listed applicant for FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)?

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

What is the FDA product code for FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)?

The FDA product code for FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) is LRC.

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Other records listing Xomed, Inc. as applicant

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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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