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FDA 510(k)

STRYKER AUTO IRRIGATION SYSTEM

K-Number: K061108 · 2007-02-02

ApplicantStryker
Decision Date2007-02-02
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STRYKER AUTO IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2007-02-02 under 510(k) number K061108. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER AUTO IRRIGATION SYSTEM?

STRYKER AUTO IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-02. The listed applicant is Stryker. The 510(k) number is K061108.

When did STRYKER AUTO IRRIGATION SYSTEM receive FDA 510(k) clearance?

STRYKER AUTO IRRIGATION SYSTEM received FDA 510(k) clearance on 2007-02-02, under 510(k) number K061108.

Who is the listed applicant for STRYKER AUTO IRRIGATION SYSTEM?

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

What is the FDA product code for STRYKER AUTO IRRIGATION SYSTEM?

The FDA product code for STRYKER AUTO IRRIGATION SYSTEM is FRN.

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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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