The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Rf20000a Controller, Flow 50 Wand.
Device ID | K143235 |
510k Number | K143235 |
Device Name: | RF20000a Controller, FLOW 50 Wand |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 |
Contact | Ashley J Dawson |
Correspondent | Ashley J Dawson ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-10 |
Decision Date | 2015-10-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817470012217 | K143235 | 000 |
00885556724668 | K143235 | 000 |
00885556617472 | K143235 | 000 |