The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ambient Super Multivac 50 Wand With Integrated Finger Switches.
Device ID | K180848 |
510k Number | K180848 |
Device Name: | AMBIENT Super MULTIVAC 50 Wand With Integrated Finger Switches |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
Contact | Shruthi Bhat |
Correspondent | Shruthi Bhat ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-02 |
Decision Date | 2018-05-01 |
Summary: | summary |