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FDA 510(k)

Halo Single-Loop Microsnare Kit

K-Number: K200963 · 2021-01-05

ApplicantArgon Medical Devices, Inc.
Decision Date2021-01-05
Product CodeMMX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Halo Single-Loop Microsnare Kit is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K200963. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halo Single-Loop Microsnare Kit?

Halo Single-Loop Microsnare Kit is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K200963.

When did Halo Single-Loop Microsnare Kit receive FDA 510(k) clearance?

Halo Single-Loop Microsnare Kit received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200963.

Who is the listed applicant for Halo Single-Loop Microsnare Kit?

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

What is the FDA product code for Halo Single-Loop Microsnare Kit?

The FDA product code for Halo Single-Loop Microsnare Kit is MMX.

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Related Devices (Code: MMX)

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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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