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FDA 510(k)

OSV II LOW FLOW LOW PRO VALVE

K-Number: K093968 · 2010-01-22

ApplicantIntegra LifeSciences Corporation
Decision Date2010-01-22
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSV II LOW FLOW LOW PRO VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2010-01-22 under 510(k) number K093968. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSV II LOW FLOW LOW PRO VALVE?

OSV II LOW FLOW LOW PRO VALVE is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K093968.

When did OSV II LOW FLOW LOW PRO VALVE receive FDA 510(k) clearance?

OSV II LOW FLOW LOW PRO VALVE received FDA 510(k) clearance on 2010-01-22, under 510(k) number K093968.

Who is the listed applicant for OSV II LOW FLOW LOW PRO VALVE?

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

What is the FDA product code for OSV II LOW FLOW LOW PRO VALVE?

The FDA product code for OSV II LOW FLOW LOW PRO VALVE is JXG.

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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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