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FDA 510(k)

BRANDT ESOPHAGEAL CYTOLOGY BALLOON

K-Number: K911588 · 1992-11-18

ApplicantWilson-Cook Medical, Inc.
Decision Date1992-11-18
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BRANDT ESOPHAGEAL CYTOLOGY BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 1992-11-18 under 510(k) number K911588. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRANDT ESOPHAGEAL CYTOLOGY BALLOON?

BRANDT ESOPHAGEAL CYTOLOGY BALLOON is a medical device that received FDA 510(k) clearance on 1992-11-18. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K911588.

When did BRANDT ESOPHAGEAL CYTOLOGY BALLOON receive FDA 510(k) clearance?

BRANDT ESOPHAGEAL CYTOLOGY BALLOON received FDA 510(k) clearance on 1992-11-18, under 510(k) number K911588.

Who is the listed applicant for BRANDT ESOPHAGEAL CYTOLOGY BALLOON?

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

What is the FDA product code for BRANDT ESOPHAGEAL CYTOLOGY BALLOON?

The FDA product code for BRANDT ESOPHAGEAL CYTOLOGY BALLOON is EOX.

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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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