The following data is part of a premarket notification filed by Parallax Medical, Inc. with the FDA for Parallax Tracer Radiopaque Particles.
| Device ID | K991893 |
| 510k Number | K991893 |
| Device Name: | PARALLAX TRACER RADIOPAQUE PARTICLES |
| Classification | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Applicant | PARALLAX MEDICAL, INC. 453 RAVENDALE DR., SUITE B Mountain View, CA 94043 |
| Contact | Susan G Marques |
| Correspondent | Susan G Marques PARALLAX MEDICAL, INC. 453 RAVENDALE DR., SUITE B Mountain View, CA 94043 |
| Product Code | MYU |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-03 |
| Decision Date | 1999-08-13 |
| Summary: | summary |