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FDA 510(k)

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

K-Number: K080845 · 2008-04-30

ApplicantCardinalhealth
Decision Date2008-04-30
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K080845. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM?

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Cardinalhealth. The 510(k) number is K080845.

When did ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM receive FDA 510(k) clearance?

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080845.

Who is the listed applicant for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM?

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

What is the FDA product code for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM?

The FDA product code for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM is JCX.

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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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