The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Arthrocare Coblator Iq Dlr Spinewand, Arthrocare Coblator Iq Dlg Spinewand.
| Device ID | K132099 |
| 510k Number | K132099 |
| Device Name: | ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 -0000 |
| Contact | Shirley Hyink |
| Correspondent | Shirley Hyink ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin, TX 78735 -0000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2013-08-22 |
| Summary: | summary |