The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Parallax Ezflow Cement Delivery System.
| Device ID | K051820 |
| 510k Number | K051820 |
| Device Name: | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM |
| Classification | Injector, Vertebroplasty (does Not Contain Cement) |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | OAR |
| CFR Regulation Number | 888.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-09-06 |
| Summary: | summary |