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FDA 510(k)

V-BAG WITH GBS COATING

K-Number: K050195 · 2005-03-17

ApplicantGish Biomedical, Inc.
Decision Date2005-03-17
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V-BAG WITH GBS 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 2005-03-17 under 510(k) number K050195. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-BAG WITH GBS COATING?

V-BAG WITH GBS COATING is a medical device that received FDA 510(k) clearance on 2005-03-17. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K050195.

When did V-BAG WITH GBS COATING receive FDA 510(k) clearance?

V-BAG WITH GBS COATING received FDA 510(k) clearance on 2005-03-17, under 510(k) number K050195.

Who is the listed applicant for V-BAG WITH GBS 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 V-BAG WITH GBS COATING?

The FDA product code for V-BAG WITH GBS COATING is DTN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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