The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare System 12000.
Device ID | K071709 |
510k Number | K071709 |
Device Name: | ARTHROCARE SYSTEM 12000 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-22 |
Decision Date | 2007-08-07 |
Summary: | summary |