The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Ambient Turboflash 90 Ifs.
| Device ID | K120791 |
| 510k Number | K120791 |
| Device Name: | AMBIENT TURBOFLASH 90 IFS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick ARTHOCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE BUILDING ONE 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 | 2012-03-15 |
| Decision Date | 2012-12-11 |
| Summary: | summary |