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FDA 510(k)

LINVATEC 10K IRRIGATION SYSTEM

K-Number: K033573 · 2004-02-11

ApplicantLinvatec Corp.
Decision Date2004-02-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINVATEC 10K IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2004-02-11 under 510(k) number K033573. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINVATEC 10K IRRIGATION SYSTEM?

LINVATEC 10K IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-11. The listed applicant is Linvatec Corp.. The 510(k) number is K033573.

When did LINVATEC 10K IRRIGATION SYSTEM receive FDA 510(k) clearance?

LINVATEC 10K IRRIGATION SYSTEM received FDA 510(k) clearance on 2004-02-11, under 510(k) number K033573.

Who is the listed applicant for LINVATEC 10K IRRIGATION SYSTEM?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINVATEC 10K IRRIGATION SYSTEM?

The FDA product code for LINVATEC 10K IRRIGATION SYSTEM is HRX.

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Other records listing Linvatec Corp. as applicant

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Related Devices (Code: HRX)

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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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