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FDA 510(k)

GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING

K-Number: K051606 · 2005-08-12

ApplicantGish Biomedical, Inc.
Decision Date2005-08-12
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GISH ATR2900 AND CAP35 SERIES RESERVOIRS 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 2005-08-12 under 510(k) number K051606. 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 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING?

GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING is a medical device that received FDA 510(k) clearance on 2005-08-12. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K051606.

When did GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING receive FDA 510(k) clearance?

GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING received FDA 510(k) clearance on 2005-08-12, under 510(k) number K051606.

Who is the listed applicant for GISH ATR2900 AND CAP35 SERIES RESERVOIRS 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 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING?

The FDA product code for GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING is DTN.

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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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