The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Spinewands.
Device ID | K070851 |
510k Number | K070851 |
Device Name: | ARTHROCARE SPINEWANDS |
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 | 2007-03-28 |
Decision Date | 2007-04-13 |
Summary: | summary |