The following data is part of a premarket notification filed by Cardinal Health with the FDA for Radiopaque Bone Cement.
| Device ID | K043518 |
| 510k Number | K043518 |
| Device Name: | RADIOPAQUE BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Cardinal Health 1430 WAUKEGAN RD. BUILDING KB Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols Cardinal Health 1430 WAUKEGAN RD. BUILDING KB Mcgaw Park, IL 60085 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-05-11 |
| Summary: | summary |