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 |