Bone Cement Radio-Opacifier
FDA 510(k) K032388 · Cardinalhealth
510(k) numberK032388
Submission
- Device name
- Bone Cement Radio-Opacifier
- Applicant
- Cardinalhealth
Waukegan, IL, US - Received
- August 4, 2003
- Decision date
- October 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MYU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033230 | Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special | Parallax Medical, Inc. | 12/12/2003SE |
| K024359 | Vista Scientific Barium Sulfate, Model 3001-1MYU · Abbreviated | Vista Scientific, LLC | 08/08/2003SE |
| K023445 | Tracers Bone Cement OpacifierMYU · Special | Parallax Medical, Inc. | 03/11/2003SE |
| K002063 | Biotrace, Model 1730MYU · Traditional | Bryan Corp. | 08/10/2000SE |
| K991893 | Parallax Tracer Radiopaque ParticlesMYU · Traditional | Parallax Medical, Inc. | 08/13/1999SE |
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Questions and answers
When was Bone Cement Radio-Opacifier cleared by the FDA?
Bone Cement Radio-Opacifier (K032388) received a 510(k) decision of Substantially Equivalent on October 31, 2003, 88 days after the submission was received.
What is the product code of K032388?
The FDA product code is MYU – Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.