The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands.
Device ID | K021519 |
510k Number | K021519 |
Device Name: | ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
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 | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-10 |
Decision Date | 2002-06-06 |
Summary: | summary |