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FDA 510(k)

MAGNUM FLOW IRRIGATION SYSTEM

K-Number: K010519 · 2001-05-14

ApplicantScion Valley, Inc.
Decision Date2001-05-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGNUM FLOW IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scion Valley, Inc.. It received FDA 510(k) clearance on 2001-05-14 under 510(k) number K010519. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNUM FLOW IRRIGATION SYSTEM?

MAGNUM FLOW IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Scion Valley, Inc.. The 510(k) number is K010519.

When did MAGNUM FLOW IRRIGATION SYSTEM receive FDA 510(k) clearance?

MAGNUM FLOW IRRIGATION SYSTEM received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010519.

Who is the listed applicant for MAGNUM FLOW IRRIGATION SYSTEM?

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

What is the FDA product code for MAGNUM FLOW IRRIGATION SYSTEM?

The FDA product code for MAGNUM FLOW IRRIGATION SYSTEM is GCJ.

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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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