The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Arthro Wands, Enetec Evac Plasma Wand.
Device ID | K013463 |
510k Number | K013463 |
Device Name: | ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
Contact | Bruce Prothro |
Correspondent | Bruce Prothro ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-18 |
Decision Date | 2001-11-15 |
Summary: | summary |