The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands.
| Device ID | K020621 |
| 510k Number | K020621 |
| Device Name: | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS |
| Classification | Motor, Surgical Instrument, Ac-powered |
| 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 | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-26 |
| Decision Date | 2002-03-28 |
| Summary: | summary |