The following data is part of a premarket notification filed by Cardinal Health with the FDA for Bone Cement Radio-opacifier.
| Device ID | K032388 |
| 510k Number | K032388 |
| Device Name: | BONE CEMENT RADIO-OPACIFIER |
| Classification | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols Cardinal Health 1500 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | MYU |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-31 |
| Summary: | summary |