The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, And Visage Wandsff.
| Device ID | K020408 |
| 510k Number | K020408 |
| Device Name: | SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Bruce Prothro |
| Correspondent | Bruce Prothro ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-07 |
| Decision Date | 2002-05-02 |
| Summary: | summary |