The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Paragon T2 Wand With Integrated Cable.
| Device ID | K153675 |
| 510k Number | K153675 |
| Device Name: | Paragon T2 Wand With Integrated Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 W. WILLIAM CANNON DRIVE Austin, TX 78735 |
| Contact | Krystle Danuz |
| Correspondent | Krystle Danuz ARTHROCARE CORPORATION 7000 W. 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 | 2015-12-21 |
| Decision Date | 2016-01-15 |
| Summary: | summary |