FDA 510(k)

BONE CEMENT RADIO-OPACIFIER

K-Number: K032388 · 2003-10-31

Decision Date2003-10-31

Product CodeMYU

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BONE CEMENT RADIO-OPACIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2003-10-31 under 510(k) number K032388. The device is classified under product code MYU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE CEMENT RADIO-OPACIFIER?

BONE CEMENT RADIO-OPACIFIER is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Cardinalhealth. The 510(k) number is K032388.

When did BONE CEMENT RADIO-OPACIFIER receive FDA 510(k) clearance?

BONE CEMENT RADIO-OPACIFIER received FDA 510(k) clearance on 2003-10-31, under 510(k) number K032388.

Who is the listed applicant for BONE CEMENT RADIO-OPACIFIER?

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 BONE CEMENT RADIO-OPACIFIER?

The FDA product code for BONE CEMENT RADIO-OPACIFIER is MYU.

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Related Devices (Code: MYU)

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAParallax Medical, Inc.K024359VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1Vista Scientific, LLC K023445TRACERS BONE CEMENT OPACIFIERParallax Medical, Inc.K002063BIOTRACE, MODEL 1730Bryan Corp.K991893PARALLAX TRACER RADIOPAQUE PARTICLESParallax Medical, Inc.

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.