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FDA 510(k)

GISH TUBING AND CONNECTORS WITH HA COATING

K-Number: K081881 · 2009-01-23

ApplicantGish Biomedical, Inc.
Decision Date2009-01-23
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GISH TUBING AND CONNECTORS WITH HA COATING is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 2009-01-23 under 510(k) number K081881. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GISH TUBING AND CONNECTORS WITH HA COATING?

GISH TUBING AND CONNECTORS WITH HA COATING is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K081881.

When did GISH TUBING AND CONNECTORS WITH HA COATING receive FDA 510(k) clearance?

GISH TUBING AND CONNECTORS WITH HA COATING received FDA 510(k) clearance on 2009-01-23, under 510(k) number K081881.

Who is the listed applicant for GISH TUBING AND CONNECTORS WITH HA COATING?

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

What is the FDA product code for GISH TUBING AND CONNECTORS WITH HA COATING?

The FDA product code for GISH TUBING AND CONNECTORS WITH HA COATING is DWF.

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Related Devices (Code: DWF)

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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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