The following data is part of a premarket notification filed by Parallax Medical, Inc. with the FDA for Tracers Bone Cement Opacifier.
| Device ID | K023445 |
| 510k Number | K023445 |
| Device Name: | TRACERS BONE CEMENT OPACIFIER |
| Classification | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Applicant | PARALLAX MEDICAL, INC. 940 DISC DR. Scotts Valley, CA 95066 -4544 |
| Contact | Linda Bradley |
| Correspondent | Linda Bradley PARALLAX MEDICAL, INC. 940 DISC DR. Scotts Valley, CA 95066 -4544 |
| Product Code | MYU |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2003-03-11 |
| Summary: | summary |