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FDA 510(k)

GRADUATED ADAPTER WITH CLAVE

K-Number: K080007 · 2008-05-13

ApplicantIcu Medical, Inc.
Decision Date2008-05-13
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GRADUATED ADAPTER WITH CLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K080007. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRADUATED ADAPTER WITH CLAVE?

GRADUATED ADAPTER WITH CLAVE is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Icu Medical, Inc.. The 510(k) number is K080007.

When did GRADUATED ADAPTER WITH CLAVE receive FDA 510(k) clearance?

GRADUATED ADAPTER WITH CLAVE received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080007.

Who is the listed applicant for GRADUATED ADAPTER WITH CLAVE?

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

What is the FDA product code for GRADUATED ADAPTER WITH CLAVE?

The FDA product code for GRADUATED ADAPTER WITH CLAVE is EZD.

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Related Devices (Code: EZD)

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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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