K032388 is an FDA 510(k) clearance for the BONE CEMENT RADIO-OPACIFIER. This device is classified as a Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code MYU).
Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on October 31, 2003, 88 days after receiving the submission on August 4, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K032388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2003 |
| Decision Date | October 31, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MYU — Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5300 |